Associate Director, PV Quality Management
1 week ago
We are seeking an experienced Associate Director to lead our Pharmacovigilance Quality team. The successful candidate will provide quality oversight and support to our pharmacovigilance system and activities, ensuring compliance with global regulations and guidelines.
Key Responsibilities- Develop and implement quality strategies to ensure compliance with global pharmacovigilance regulations and guidelines.
- Lead audits of our pharmacovigilance system, including processes, systems, vendors, and affiliates.
- Collaborate with cross-functional teams to ensure quality and compliance in our pharmacovigilance activities.
- Provide training and mentoring to junior staff members.
- Develop and maintain annual audit plans for our pharmacovigilance quality program.
- Participate in regulatory authority inspections and provide input on responses to inspection findings.
- BS/BA, MS or PhD/PharmD with a minimum of 10, 8, or 6 years of experience, respectively, in biotech, pharma, or clinical research organization.
- Audit certification (e.g., ASQ Lead Auditor) preferred.
- Strong knowledge of global pharmacovigilance regulations and guidelines.
- Experience working with CROs, vendors, and relationship management.
- Strong interpersonal and leadership skills.
We offer a comprehensive benefits package, including medical, dental, and vision coverage, flexible spending accounts, and a generous paid time off policy.
We are an equal opportunity employer and welcome applications from diverse candidates. We are committed to creating a culture of belonging and inclusion.
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