Medical Director, Immunology, Global Patient Safety
About The Position
The Medical Director supports the Product Safety Lead (PST) in ensuring the safety of one or more products through surveillance, signal detection, validation, and assessment. The role interprets regulations related to pharmacovigilance and supports patient safety activities. It applies knowledge of pharmacology, chemistry, and non-clinical toxicology to safety surveillance of pharmaceutical, biological, and drug-device combination products. The position contributes to pharmacovigilance documents, analyzes and communicates aggregate safety data to cross-functional teams, and writes, reviews, and provides input on technical documents under the guidance of the PST Lead.
Requirements
- MD or DO with at least 2 years of residency and patient management experience.
- Ability to analyze clinical data and epidemiological information.
- Ability to write technical documents with direction.
- Ability to work collaboratively in a team and independently as a self-starter.
- Ability to effectively present recommendations and opinions in a group environment.
- Fluency in written and spoken English.
Nice To Haves
- Master of Public Health in addition to an MD or DO.
Responsibilities
- Support the Product Safety Lead in ensuring product safety through surveillance, signal detection, validation, and assessment.
- Interpret pharmacovigilance regulations and support patient safety activities.
- Apply pharmacology, chemistry, and non-clinical toxicology knowledge to safety surveillance.
- Conduct safety surveillance for pharmaceutical, biological, and drug-device combination products.
- Contribute to pharmacovigilance documents, including medical safety assessments, regulatory responses, and risk management plans.
- Apply current regulatory guidance to safety surveillance and pharmacovigilance document authorship.
- Analyze and interpret aggregate safety data and communicate the analysis and interpretation to cross-functional teams.
- Under the guidance of the PST Lead, write, review, and provide input on technical documents.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
