A biotech company is seeking an Associate Director of Pharmacovigilance Operations based in Concord, MA. This hybrid role involves overseeing vendor performance in post-marketing pharmacovigilance, ensuring compliance with FDA and international regulations, and leading training initiatives. Candidates should have 8-10+ years of experience and a strong track record in managing service providers. The position offers a competitive salary package between $195,000 and $215,000, plus benefits for professional development and well-being.
Qualifications
8–10+ years of relevant experience in pharmacovigilance in the biotech or pharmaceutical industry.
Demonstrated track record of managing PV service providers.
Strong foundation with FDA regulations and experience with international pharmacovigilance.
Responsibilities
Oversee day-to-day vendor operations in pharmacovigilance.
Ensure timely transmission of AE reports to the global team.
Lead coordination of PV Awareness training for staff and vendors.
Skills
Pharmacovigilance expertise
Regulatory compliance
Strong communication
Vendor management
Education
Bachelor’s degree in pharmacy, nursing, life sciences, or healthcare field
PharmD or advanced degree
Job description
A biotech company is seeking an Associate Director of Pharmacovigilance Operations based in Concord, MA. This hybrid role involves overseeing vendor performance in post-marketing pharmacovigilance, ensuring compliance with FDA and international regulations, and leading training initiatives. Candidates should have 8-10+ years of experience and a strong track record in managing service providers. The position offers a competitive salary package between $195,000 and $215,000, plus benefits for professional development and well-being.