Medical Director, Safety Physician

San Diego, CA, United States
Feb 22, 2019
Required Education
Bachelors Degree
Position Type
Full time

This is an important leadership position within the company which has considerable responsibility for the medical safety management of drugs in development and in post-marketing. The position requires strong analytical skills and the capability to effectively work as a strong team player. This position will lead the ongoing signal detection monitoring, product risk-benefit assessment, interacting with health authorities in United States (US) and external to US, and patient drug-safety assessment activities of designated drugs and/or indications. The Medical Director will oversee the Pharmacovigilance department staff and in addition will be a key member in one or more cross functional clinical development and post-marketing teams.

Duties and Responsibilities Include But Are Not Limited To:

  • Serving as the Safety Physician for the lead product(s) in the portfolio
  • Providing medical and clinical review and assessment of cases during conduct of clinical trials as well as post-marketing.
  • Representing Medical Drug Safety in communications with health and regulatory authorities which may include labeling
  • Representing Medical Drug Safety at independent Data Safety Monitoring Committee meetings as needed
  • Compiling analysis of similar events (AOSE), individual case comments, REMS/RMP analyses, and ad-hoc safety analyses as required by health authorities or corporate policy
  • Providing medical input for maintaining REMS, RMP, and post-marketing safety monitoring commitments
  • Providing periodic benefit-risk assessment reports for internal use
  • Investigating emerging safety data from various sources, ideally including: identifying safety trends and adverse events of interest for the lead product(s) across ongoing clinical trials, reviewing individual clinical trial AE/SAE case reports, spontaneous Adverse Drug Reaction (ADR) reports, published literature, aggregate reports, toxicology reports, non-clinical studies, and other sources
  • Contributes to the preparation of, reviews, and approves aggregate safety reports required by health authorities such as, Development Safety Update Reports (DSUR), US Periodic Adverse Drug Experience report, etc.
  • Authors, reviews and provides input and approval for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), , clinical study reports, patient narratives, MedDRA coding of AEs, product package labeling, Summary of Product Characteristics (SPC), Company Core Safety Information (CCSI)), etc.
  • Leads internal cross-functional safety review committee meetings
  • As the Sponsor representative, works collaboratively and participates in Pharmacovigilance vendor meetings
  • Establishing Standard Operating Procedures for Drug Safety and Pharmacovigilance
  • Other duties as assigned

Desired Knowledge and Abilities:

  • Strong skills in the management of safety information originating from both clinical development and post-marketing sources
  • Expert knowledge of the regulations governing pharmacovigilance
  • Knowledgeable of industry standard pharmacovigilance and safety related databases
  • Strong Leadership skills and ability to communicate with individuals at all levels)
  • Excellent oral and written communication skills
  • Excellent analytical skills and ability to work independently
  • Strong interpersonal, negotiating and team building skills
  • Strong experience working with/managing pharmacovigilance vendors

Education and Experience:
  • United States Doctor of Medicine(preferred), US board certification or board eligibility(preferred)
  • Preferred specialties include: Medical and Oncology
  • Minimum 5 years of experience in the role of Safety Officer or similar Pharmacovigilance leadership role in the pharmaceutical industry
  • Minimum 3 years of managing a team of direct reports
  • Safety experience with clinical trials and with approved drugs
  • Experience in the drug approval process