A leading biopharmaceutical company in San Diego is seeking a Senior Director of Safety and Pharmacovigilance to manage Safety and PV activities. This role involves ensuring compliance with global regulatory requirements while overseeing the preparation of safety-related documentation. The ideal candidate has at least 5 years of relevant experience in a biopharma organization and possesses a healthcare professional background. The company offers a great culture and comprehensive benefits including medical coverage and a 401(k) plan.
Qualifications
Minimum of 5 years of Drug Safety and PV experience.
Strong understanding of global Safety and PV regulations.
Ability to work effectively both independently and in a team setting.
Responsibilities
Oversee global Safety and PV activities for compliance.
Lead preparation of safety-related regulatory documents.
Manage vendor relationships and ensure compliance.
Skills
Drug Safety and Pharmacovigilance experience
Interpersonal skills
Project management
Problem-solving abilities
Communication skills
Education
Health care professional background (e.g., MD, RN, BSN, PharmD, Physician Assistant)
Tools
Safety databases (e.g. Argus)
MedDRA coding
Job description
A leading biopharmaceutical company in San Diego is seeking a Senior Director of Safety and Pharmacovigilance to manage Safety and PV activities. This role involves ensuring compliance with global regulatory requirements while overseeing the preparation of safety-related documentation. The ideal candidate has at least 5 years of relevant experience in a biopharma organization and possesses a healthcare professional background. The company offers a great culture and comprehensive benefits including medical coverage and a 401(k) plan.