Pharmacovigilance Physician Growing BioPharma

Job Type: Contract
Region: USA West Coast
Location: California
Salary: DOE
Posted: January 17, 2017
Ref: TYHDPV1

Position Summary:

My client are looking for a Pharmacovigilance Physician 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.
  • Review, documents and escalates concerns and issues to PV 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.
  • 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
  • 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.
  • 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

About Your Consultant

As a U.S Contracts Consultant, I specialise in the provision of Pharmaceutical staff to established and exciting Pharma, CRO’s and Medical Device companies across North America and Canada.

Email: Thodges@barringtonjames.com Telephone: 646 415 8221

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