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Job Details

Pharmacovigilance Scientist

Company: Barrington James Scientific
Location: San Francisco
Reference: TYHDPVGS
Closing Date: 17 Nov 16
Type: Contract
Salary (£): Negotiable

Job Summary:

Get In contact ASAP for this exciting and popular position. Applications are likely to close early due to demand and high caliber candidates. 646-415-8221 /


Position Summary:

My client are looking for a Pharmacovigilance Scientist who will provide PVG expertise for deliverables associated with signal detection, safety and benefit-risk evaluations for my client.  The PVGS will have the following responsibilities.

Clinical Trial Safety:

  • Review study protocols, statistical analysis plans and other clinical study-related documents.
  • Review standard design of tables, figures and listings for safety data from clinical studies.
  • Contribute to the assessment of clinical trial vendors for outsourcing projects and communicates business needs effectively of PV management.
  • Perform detailed vendor oversight activities including review of metrics and deliverables from vendors.
  • Review, documents and escalates concerns and issues to PV management.

Signal Detection, Evaluation and Management:

  • Performs proactive safety monitoring and signal detection
  • Completes initial assessment of safety signals and prioritizes safety signals for full evaluation
  • Completes initial assessment of safety signals and prioritizes safety signals for full evaluation
  • Draft the evaluation and prepare response documents of safety signals to answer internal and/or external requests
  • Perform case series review or review of tabulated data and prepare interpretation of reviewed data.

Risk Management and Minimization:

  • Draft section(s) of the Risk Management Plan (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS), oversee the maintenance of these documents, and provide oversight/coordination of the implementation of the RMP/REMS requirements

Periodic (Aggregate) Safety Reporting:

  • Provide input into the preparation and coordination of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.) for submission to the health authorities and other stakeholders

Submissions and other regulatory filings

  • Assist in the preparation of safety assessments and evaluations for ad hoc regulatory safety reports such as responses to health authorities’ requests, Health Hazard Evaluation, and responses to inquiries from internal and external customers
  • Provides PV input to the development of product Reference Safety Information (Core Company Safety Information, US Package Insert, Developmental Core Safety Information, Investigators Brochure, etc), Summary of Clinical Safety, Integrated Summary of Safety, etc. in collaboration with the PV physician

Case management:

  • Case processing, triage of incoming reports for initial assessment of seriousness, expectedness, causality, and reportability, and generation of clinically relevant SAE queries to obtain missing information and active follow-up via verbal or written contact with healthcare professionals and consumers

Minimum Basic Qualifications:

  • MD with 1-3 years of experience in drug safety, pharmacovigilance and risk management, Pharmacy degree with at least 3 year PV experience, or MS in health-related field or BSN with 4 or more years PV experience within a major pharmaceutical or biotechnology company
  • In depth understanding of medical terminology
  • In depth knowledge of global clinical and post marketing safety regulations, guidances, and reporting processes
  • Must be detail-oriented and must have strong organizational and communication skills
  • Experience with MedDRA coding and ARGUS safety database system

Preferred Qualifications and Experience:

  •  At least 3 years of biotech/pharmaceutical industry experience, including at least 2 year of experience in clinical safety / Pharmacovigilance.
  •   2-3 years relevant clinical safety, regulatory, or risk management experience strongly preferred
  • Knowledge and experience with medical safety review, safety surveillance, signal detection, labeling analyses, and ad hoc safety analyses.
  • Data entry and MedDRA coding experience; ARGUS experience preferred.
  • Experience in the reviews of relevant safety information from all sources and analysis of safety data.
  • Experience with development, authorship and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies 

Apply for this job: Pharmacovigilance Scientist

Contact Information:

Address:  Head Office
Rowan House
Smallfield Road
Tel:  01293 776644

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