Medical Director, Safety Physician

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