Medical Director, Neuroscience, Global Patient Safety

Purpose:
- Lead Product Safety Teams (PST) and support one or more products as the PST Lead to ensure product safety profiles are adequately monitored and characterized throughout the product lifecycle (surveillance, signal detection/evaluation, risk management, etc.).
- Interpret pharmacovigilance regulations supporting patient safety activities.

Responsibilities:
- Apply pharmacology, chemistry, and non-clinical toxicology to conduct safety surveillance.
- Ensure safety surveillance for pharmaceutical/biological/drug-device combination products.
- Lead, oversee, and set strategy for key pharmacovigilance documents (e.g., medical safety assessments, regulatory responses, risk management plans, periodic safety reports such as DSURs, PBRERs/PSURs, PADERs).
- Lead and oversee pharmacovigilance for products in clinical development and marketed products per regulatory guidance.
- Analyze and interpret aggregate safety data and communicate findings to cross-functional teams and regulatory authorities.
- Independently write, review, and present technical documents.
- Implement risk management strategies for assigned products.
- Proactively engage, coach, and mentor team members.

Qualifications:
- MD/DO with 2+ years of residency with patient management experience.
- MPH preferred (not required).
- 2–5 years of Pharmacovigilance/Clinical Development experience in the pharmaceutical industry.
- Ability to analyze and guide analysis of clinical/epidemiological data.
- Present recommendations internally and externally.
- Write, review, and provide input on technical documents.
- Collaborate with and lead cross-functional teams.
- Fluency in written and oral English.
- Ability to make independent decisions in uncertainty/complexity and multitask.

Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for long-term incentive programs.