Head of Medical Safety and Risk Management
7 days ago
We are seeking a highly experienced and skilled Senior Director of Pharmacovigilance and Medical Safety to join our team at Acadia Pharmaceuticals Inc. This is a critical role that requires a strong background in drug safety, regulatory compliance, and leadership.
Key Responsibilities- Develop and Implement Safety Strategies
Develop and implement strategies to achieve pharmacovigilance and medical safety goals, working closely with the Head of Safety and other stakeholders.
Represent PV in Communications with Health AuthoritiesRepresent the Pharmacovigilance department in communications with health authorities such as the FDA, ensuring compliance with regulatory requirements.
Assess and Manage Safety SignalsAssess safety signals and trends, and proactively manage any potential safety issues, ensuring timely communication to stakeholders.
Author Responses to Health Authority RequestsFormulate response strategies and author responses to health authority requests, ensuring compliance with regulatory requirements.
Ensure Compliance with RegulationsEnsure that pharmacovigilance and medical safety activities are performed in compliance with all applicable regulations and company standards.
Requirements- MD Degree or Equivalent
A medical degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.
12+ Years of Relevant ExperienceTargeting 12 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including safety leadership experience.
Strong Analytical and Communication SkillsHighly-developed scientific and analytical knowledge base, excellent understanding of good pharmacovigilance practices, and strong communication skills.
What We Offer- Competitive Compensation and Benefits
Competitive base, bonus, new hire and ongoing equity packages, medical, dental, and vision insurance, 401(k) Plan with a fully vested company match, and Employee Stock Purchase Plan.
Opportunities for Growth and DevelopmentOpportunities for growth and development, including tuition assistance and paid parental leave.
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