Senior Director of Pharmacovigilance and Medical Safety
1 week 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 will play a key part in ensuring the safety of our products and maintaining the trust of our stakeholders.
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 that our company's interests are represented and that we are in compliance with all relevant regulations.
Assess and Manage Safety SignalsAssess safety signals and trends, and proactively manage any potential safety issues that may arise, working closely with the Head of Safety and other stakeholders.
Formulate Response Strategies and Author ResponsesFormulate response strategies and author responses to health authority requests, ensuring that our company's interests are represented and that we are in compliance with all relevant regulations.
Ensure Compliance with RegulationsEnsure that all pharmacovigilance and medical safety activities are performed in compliance with all applicable regulations and company standards.
Lead Development of Risk Management PlansLead the development of Risk Management Plans, implementation and evaluation of their effectiveness, ensuring that our company's products are safe and effective for our customers.
Communicate Safety Issues to StakeholdersCommunicate safety issues to the appropriate stakeholders in a timely fashion, ensuring that our company's interests are represented and that we are in compliance with all relevant regulations.
Requirements- MD Degree or Equivalent
A MD 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.
Highly Developed Scientific and Analytical KnowledgeHighly-developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
Excellent Communication and Leadership SkillsExcellent written and verbal communication skills, with the ability to think strategically at the executive level, implement change, incorporate innovation, and implement strategies throughout all levels of the organization.
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 1:1 up to 5%, Employee Stock Purchase Plan with a 2-year purchase price lock-in, 15+ vacation days, 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st, 10 days of paid sick time, paid parental leave, and tuition assistance.
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