Medical Director, Safety Physician

Location
San Diego, CA, United States
Posted
Feb 22, 2019
Ref
oLfd9fw6
Required Education
Bachelors Degree
Position Type
Full time
Function/Scope:

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