San Diego, CA
Senior Medical Director
We are in immediate need of a Senior Medical Director of Drug Safety & Pharmacovigilance for the Research and Development Headquarters of our biopharma company. We are focused on the development of novel synthetic bile acid analogs to treat chronic liver diseases. The Senior Medical Director will accept 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, and patient drug-safety assessment activities of designated drugs and/or indications. The Senior Medical Director will work closely with the Pharmacovigilance department staff and in addition will be a key member in one or more cross functional clinical development and post-marketing teams.
This position assumes responsibility for:
• Serving as the Safety Officer (medical monitor) for designated indications or drug portfolio(s) including providing after hours coverage for urgent/emergent medical queries related to clinical study conduct and patient safety.
• Providing medical significance and expectedness assessment of AE/SAE reports and approving AE/SAE case narratives
• Representing Medical Drug Safety in communications with health and regulatory authorities
• Representing Medical Drug Safety at independent Data Safety Monitoring Committee meetings
• 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 and reviewing emerging safety data from various sources including 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), Periodic Benefit-Risk Evaluation Reports (PBRER), 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), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, , product package labeling, Summary of Product Characteristics (SPC), Company Core Safety Information (CCSI))
• Doctor of Medicine, US board certification or board eligibility preferred but not mandatory.
• Preferred specialties include Gastroenterology, Internal Medicine
• 5 years minimum experience in the role of safety officer or similar pharmacovigilance leadership role in the pharmaceutical industry
o Strong skills in the management of safety information originating from both clinical development and post-marketing sources
o Expert knowledge of the regulations governing pharmacovigilance
o Working knowledge of industry standard pharmacovigilance databases