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 | Location  | City | Job Type | Job Title | Category | Status |  |
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| IL | Lake Forest | Temporary | Clinical Drug Safety Specialist | Clinical | Open | | | Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed product. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Ensure effective and accurate collection, database entry, review and reporting of safety data.
- Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed product.
- Assist in signal generation and safety analysis activities
Position Responsibilities - QC review and follow-up assessment of local safety case reports.
- QC of expedited reporting submission documents for case reports.
- Ensure quality of case processing/reporting by providing feedback to Case Processing group.
- Review of local/global case reports to determine regional reportability.
- Represent pharmacovigilance department in cross-functional teams or committees that have global study or program impact.
- Assist with narrative writing for periodic/ad hoc submissions.
- Assist with ad hoc or routine safety monitoring activities.
Position Requirements - Registered nurse or Bachelors degree required; scientific/medical field preferred
- Minimum 2 years experience in healthcare, clinical or pharmacovigilance-related area.
- Experience with safety databases including simple searches & coding dictionaries (MedDRA) is desired.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | NJ | Plainsboro | Temporary | Clinical Drug Safety Specialist | Clinical | Open | | | Provides product information support within the Drug Information Center, Medical Information Department for the Immunology portfolio of products. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Identify, assess and appropriately manage safety signals Phase 1- Phase 4.
Position Responsibilities
- Provides product information support within the Drug Information Center, Medical Information Department for the Immunology portfolio of products.
- Individual will be responsible for providing product information to both health care practitioners and patients.
- As part of Medical Information team, this individual will be responsible for the assuring complete and balanced medical information for transplant and rheumatology products.
- When necessary, captures and reports adverse event and product quality complaints to Global Pharmacovigilance.
- Updates and ensures compliance to medical information standard work practices and procedures.
Position Requirements - Pharmacist or PharmD with a minimum of 3-5 years pharmaceutical industry experience in medical information or medically related responsibilities.
- Experience in intravenous drug preparation preferred.
- Ability to communicate on professional level with physicians, nurses, pharmacists and other professional staff when discussing products.
- Have appropriate training and sensitivity to legal and regulatory issues for medical information.
- Have general knowledge of information technology and integrates potential applications to assess medical information delivery.
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| | | We currently do not have any other open positions that match your criteria, but new positions could become available at any time. Below is a sampling of the type of positions that we have had available in the past that match your search criteria. | | |
| | | CA | Fremont | Temporary | Clinical Drug Safety Specialist | Clinical | Filled | | |
Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Global Safety Specialist III
Position Responsibilities - General first level consultation on health issues that reduce the need for employees’ time away from work
- Early reporting and care of all injuries and illness
- Case management and return to work accommodation
- General management of onsite clinic facility
- Triage for cases involving health and wellbeing
- Involvement in health promotion
- Company Liaison with off site Occupational Health resources
- Assistance in providing information related to case management when needed by Legal Department
- Provision for confidentiality of medical information under HIPPA and OSHA
- Compliance with Californiaspecific regulations (for example first aid requirements).
- Vaccinations for seasonal and pandemic flu
- Compliance with medical surveillance requirements
- Provision of vision exams where needed for GMP compliance
- Travel consultation for health
- Coordination with risk management for medical emergency response
Position Requirements · SRN or other medical equivalency · Ability to conduct ergonomic assessments, encourage early reporting and preventative measures Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holidayand Vacation Pay
- Relocation Assistance
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| | | CA | Palo Alto | Temporary | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title - Sr. Drug Safety Associate- Nurse
Position Description
- The Sr. Associate will be expected to do the evaluation of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines and pertinent licensing agreements.
- The Sr. Associate will also be responsible for data entry of new cases as well as the review and approval of adverse event reports processed by others.
- The Sr. Associate may be responsible for following up with physicians and other health care professionals and consumers, as appropriate and ensure that adverse events are entered into the safety system accurately
Position Requirements - Four plus years relevant experience within the pharmaceutical industry
- Knowledge of MedDRA
- Working knowledge of pharmacovigilance and clinical safety regulations and guidelines
- Ability to independently identify problems and effectively offer solutions to problems
- Must have excellent communication skills, resourcefulness, and personal organization skills
- Must be committed to working as part of a team in a fast-paced environment. HIGH Energy!
- Experience using an established safety application (eg. ARISg, Argus, Oracle AERS, ClinTrace)
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| | | CA | Santa Clara | Temporary | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Oversight of Adverse Event Reporting for Clinical Trials
Position Responsibilities
- Medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
- Management of more junior reviewers if necessary
Position Requirements - Degree in Nursing (R.N. or B.S.N.)
- Medical review experience 1+ years
.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | CA | South San Francisco | Permanent | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
Position Description
- Process adverse event related information in drug safety database for investigational and post-marketing products, including the writing of narratives, for expedited and non-expedited reports.
Position Responsibilities
- Create simple queries using safety database in response to queries from internal and external customers.
- Track adverse event information and prepare administrative reports for management.
- Assist in developing and maintaining standard global procedures and guidelines for Drug Safety operations.
- Review, evaluate and assess adverse event information for regulatory reporting.
- Assist in completing regulatory reports, such as Periodic Reports, Periodic Safety Updates, IND Annual Reports, and other reports as needed for regulatory authorities.
- Create and generate safety information for internal use, and safety review boards.
- Interact with other company Drug Safety units in the review, processing, and reporting of safety information.
Position Requirements - Degree in Pharmacy, Nursing, or related health field, or equivalent training
- Experience in safety data management required.
- Knowledge of domestic and familiarity with international regulatory safety reporting requirements.
- Excellent organizational and problem solving skills, interpersonal skills, and the ability to work under pressure and meet tight timelines.
- Good communication skills, both written and verbal
- General knowledge of medical coding and drug dictionaries
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | CA | South San Francisco | Permanent | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leaders in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title - Manager Drug Safety Training
Position Description
- Responsible for managing the performance of Quality and Training personnel, including conducting performance reviews.
- Responsible for coaching and developing Quality and Training personnel by providing an environment that encourages ongoing personal and professional development.
- Will be expected to further develop own potential succession candidate.
- Responsible for the performance of assigned Quality and Training personnel against departmental processes, standards and performance goals, and for ensuring successful completion of all training required for Quality and Training staff.
- Responsible for ensuring implementation and continuous improvement of departmental quality and training processes that minimize procedural and systematic compliance risks while maximizing efficiency.
- Responsible for Quality and Training personnel recruiting and ongoing maintenance of department infrastructure.
- Supports Drug Safety functional groups to optimize departmental quality, standards, and training
- Collaborates with Drug Safety Senior Management to ensure that the department continuously improves operational productivity, quality and compliance.
- Collaborates with Drug Safety functional groups to identify procedural and systematic quality issues, and ensure practical, risk-based solutions that complement functional group business practices are implemented.
- Supports and/or leads functional initiatives and participates in Development initiatives.
Position Requirements - Demonstrates strong management skills including mentoring, conflict resolution, constructive guidance, and coaching.
- Communicates effectively (written and verbal) with credibility and confidence.
- Demonstrates solid decision making abilities as demonstrated by systematic information gathering and timely analysis.
- Effectively formulates strategies, tactics, and action plans to achieve results.
- Displays a high level of commitment.
- Generates enthusiasm and drive for commitment to excellence.
- Minimum of Bachelor's Degree in Life Science or the equivalent combination of relevant education and professional experience.
- Advanced scientific degree preferred.
- Minimum 5 years of pharmaceutical industry experience required, with 7 years highly desired.
- Minimum 3 years of recent personnel management experience required, preferably within the pharmaceutical industry, with 5 years highly desired.
- Strong knowledge of pharmaceutical research and development, global safety reporting activities/regulations, ICH and GXP guidelines, and pharmaceutical industry compliance activities required.
- Previous drug safety experience highly preferred.
- Experience in quality and/or training in pharmaceutical industry highly desirable.
- Excellent communication and interpersonal skills
- Computer proficiency requiredBS/MS/PhD in a life science discipline
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| | | CA | South San Francisco | Temporary | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
- Clinical Safety Associate II
Position Description
- *The Clinical Safety Associate II (CSA II) assists in the clinical processing of adverse event (AE) information received by company, responsibilities are performed under the direction of the Manager, Case Management.
- * Demonstrates advanced knowledge of safety concepts, focused on standards set
out in ICH and FDA guidelines for drug safety reporting requirements and applies
them in daily activities.
- * Performs data entry and coding for all molecules.
- * Performs a review of ancillary documentation accompanying ICSR reports and
identifies pertinent clinical information for incorporation into the case narrative.
Position Requirements - * RN, BSN, PA, NP, MSN, MD, or PharmD required
- * Minimum 2 years of clinical experience in a health care related field
- * Minimum 2 years of previous experience in Drug Safety required
- * Computer proficiency and data entry experience preferred
- * Excellent communication skills, both written and verbal
- * Previous experience in Drug Safety (preferred)
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Waukegan | Temporary | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Medical Services Specialist
Position Description
- Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests.
- Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved.
- Works with Customer Service to provide standard information and product replacement as necessary.
- Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications.
Position Responsibilities
- Disseminates medical information in accordance with established department guidelines , and regulatory guidance's with recognition of legal ramifications.
- Develops written documents regarding our pharmaceutical products that summarize pertinent clincial information from multiple sources in a accurate and concise manner utilizing the American Medical Assocation style and department guidelines.
- Develops and maintains a comprehensive understanding of pertinent drug, disease state, diagnostic and therapeutic treatment and medical knowledge to facilitate dissemination of scientifically balanced and quality medical information.
- Comprehensively communicates complex verbal and written medical information to advanced healthcare professionals to increase understanding and facilitate infromed decision-making regarding our pharmaceutical products.
Position Requirements- Bachelor's degree and graduation from a Nursing or Pharmacy program of an accredited educational organization required.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Deerfield | Temporary | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
Perform initial safety review and triage of adverse events to determine seriousness, expectedness and priority, including the timeline for response. Writes narratives summarizing all relevant medical information for individual case safety reports. Code medical terms using standardized medical dictionaries (such as MedDRA) Using expertise in therapeutic area, ensure that data has been entered and coded correctly by Data Coordinators and Medical Reviewers Perform case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters. Create and issue regulatory reports, including individual case safety reports. May also include physical submissions to affiliates or Regulatory Authorities of ICSRs, as appropriate Take initiative to recognize, prioritize & escalate potential safety/ compliance issues Interact with data coordinators, medical reviewers, MedDRA/E2B coordinator, Data Integrity/IT Liaison and other functional areas within the department to process adverse events efficiently & reliably. Collaborate with relevant counterparts in the regional & country Pharmacovigilance functions to facilitate the global exchange of safety info. Interface w/ other Sponsor groups (e.g. Quality, Regulatory, IT, Legal, business units, etc) May participate in literature review activities related to adverse event reporting with oversight from more senior Safety Review team members Working knowledge of the assigned primary therapeutic area, a backup therapeutic area, and provide other support as necessary. Participates in peer review of cases during daily rounds. Perform case clean up & trouble-shooting with guidance. Participate in call center activities related to adverse event reporting Additional responsibilities & projects as assigned Medical & clinical knowledge Excellent analytical & problem solving skills Excellent oral & written communication & interpersonal skills Operates effectively in a team environment Ability to work under strict deadlines and changing priorities with some supervision Working knowledge of ICH guidelines and other worldwide safety regulations Ability to establish priorities and proceed with accomplishing objectives Experience with a Global Safety Database Exposure to relationships with regulatory authorities RN required (US only) Bachelor’s degree in nursing or pharmacy or equivalent Experience in pharmaceutical industry; Safety or Regulatory department preferred 2-3 years hospital, patient care, or equivalent experience preferred
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| | | NJ | Nutley | Permanent | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Associate Director, Safety Scientist
Position Description
- Carrying out pharmacovigilance activities on a product or group of products, including single case processing, aggregate reporting, signal detection and evaluation of PV database
Supports the Safety Science Leader and is responsible for a particular aspect(s) or segments of the overall program.
Contributes to the benefit risk evaluation and to safety risk management.
Position Responsibilities
- Periodic safety reports (PSUR, EU Annual Safety Reports) in accordance with regulatory requirements and PDMS standard operating procedures
- Support the preparation and maintenance of safety sections of the Company Core Data Sheet
- Lead/support PDS post-marketing safety study activities
- Coordinate safety activities between PDS and internal and external partners
- Carry out signal detection activities and evaluation
- Conduct/support signal detection and evaluation according to SOPs and guidelines
- Carry out medical review of spontaneous case reports and Serious Adverse Event reports from clinical trials, according to SOPs and guidelines
- Prepare Drug Safety reports, as necessary, for potential signals
- Respond to queries relevant to the safety of Roche products from the affiliates and other internal functions
- Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products:
- Provide review of clinical protocols and study reports to ensure alignment with CDP and safety adequately addressed, and contributes to the safety section of the Investigators Brochure (IB)
- Contribute to regulatory authority submissions (NDAs, MAA's, Variations) by reviewing safety data and preparing relevant sections of the submission
- Participate in or provide input for Drug Safety Monitoring Boards, as necessary
- Provide support to the SSL
- In the case of early projects support the SSL by developing a clear understanding of the safety issues from the drug mechanism
- The timely medically and scientifically sound development of the clinical safety portions of a product development plan (PDP)
- Whenever assigned by the SSL, is responsible for the development and execution of RMP or REMS risk mitigation tactics
Position Requirements - MD is preferred but PhD, PharmD, Pharm, MS or equivalent qualification and good medical competence in the relevant therapeutic area is the minimum requirement.
- Prior experience in safety is desirable (at least 2 years)
- MD candidates with solid pharmaceutical experience in clinical development or medical affairs (at least 3 y)
- Industry experience in drug safety or clinical development
- Good knowledge of pharmacovigilance practices
- Good knowledge of US and EU pharmacovigilance regulatory requirements
- Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions
- Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
- Team player with ability to function in a multi-disciplinary environment
- Self -motivated, able to prioritize and plan effectively
- Attention to detail
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | NJ | Hopewell | Temporary | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
· Drug Safety Nurse
Position Description
· Processing and Reporting of Adverse Events
Position Responsibilities
- Ability to demonstrate work within defined departmental standards.
- Ability to organize information from rough reports into a standard format.
- An understanding of the conventions and singularities of a specific therapeutic area is a plus.
- Basic knowledge of US and international regulations surrounding the processing and reporting of adverse events.
Position Requirements · RN · 1-3 Years Experience Benefits · Blue Cross/Blue Shield Medical and Vision · Delta Dental · 401K with Company Match · Holidayand Vacation Pay · Relocation Assistance
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| | | NJ | Plainsboro | Temporary | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
- Drug Information Associate
Position Description
- Represent complete and accurate Drug Information to customers
Position Responsibilities - Solid oral and written communication skills.
- Ability to Work with call center to develop relevant, unbiased, and timely responses to customer inquiries in order to meet or exceed customer satisfaction objectives.
- Ability to critically evaluate the published medical and scientific literature and write and update relevant, unbiased custom and standard response documents and product profiles to ensure information provided to customers represents the most complete and accurate information.
Position Requirements - Pharmacist
- 1-3 years of Drug Information, internships included
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | NJ | Hopewell | Temporary | Clinical Drug Safety Specialist | Clinical | Filled | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
Position Description
Position Responsibilities - A demonstrated ability to work within defined departmental standards.
- Ability to organize information from rough reports into a standard format.
- An understanding of the conventions and singularities of a specific therapeutic area is a plus.
- Basic knowledge of US and international regulations surrounding the processing and reporting of adverse events.
Position Requirements - BS/BA degree
- 1-3 years of Drug Safety experience processing case reports
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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