Sr. Medical Director, Pharmacovigilance
M
MapLight TherapeuticsBiotechnology
This is a remote US position.Full-TimeSenior
Salary$319,000 — $361,000 USD
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Job Details
- Experience
- 3-5 years of relevant clinical experience and minimum 10 years’ industry experience
Requirements
- MD or equivalent degree.
- 3-5 years of relevant clinical experience.
- Minimum 10 years’ industry experience in Drug safety/Pharmacovigilance.
- Proven experience in safety data analysis, signal management, and benefit-risk evaluation.
- Working knowledge of safety databases (e.g., Argus, ArisG/LifeSphere Safety).
- Demonstrated ability to develop and implement drug safety strategies and risk management plans.
- Experience authoring or contributing to clinical study and regulatory submission documents (NDA/IND).
- Knowledge of local and global regulatory requirements.
- Ability to travel up to 10% for meetings.
- Board Certification/Eligibility in Neurology or psychiatry preferred.
Responsibilities
- Lead product safety surveillance and monitor evolving benefit-risk profiles.
- Manage cross-functional safety management teams (SMT).
- Conduct signal detection, evaluation, interpretation, and communication of safety information.
- Represent pharmacovigilance on product teams and review safety sections of protocols and regulatory documents.
- Develop and maintain risk management documents (DRMPs, RMPs, REMS).
- Perform medical review of adverse event reports for seriousness, expectedness, and causality.
- Manage and mentor safety scientists supporting surveillance activities.
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