BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Life Sciences community. We are currently looking for a (6mo) Contract Associate Director of Pharmacovigiliance Sciences to work for a leading San Diego area pharmaceutical company.
Key Responsibilities:
- Manage all pharmacovigilance activities for assigned products or therapeutic areas.
- Prepare and submit pharmacovigilance aggregate reports (e.g., DSUR, PBRER) in collaboration with safety physicians and stakeholders.
- Compile safety data for regulatory submissions, post-marketing assessments, and label updates.
- Lead the review and approval process of pharmacovigilance reports, coordinating with safety physicians and external vendors.
- Conduct safety surveillance and signal detection activities for assigned products.
- Organize and lead Safety Review Team (SRT) meetings, ensuring that all regulatory and Risk Management Plan (RMP) commitments are tracked and addressed.
- Represent pharmacovigilance in clinical programs, collaborate with Regulatory Affairs on expedited safety reports, and support Drug Safety Monitoring Boards.
- Provide guidance and oversight to vendors supporting pharmacovigilance activities for investigational and marketed products.
- Participate in PV audits and regulatory inspections as a subject matter expert.
*Occasional travel up to 15% may be required.
Qualifications:
-Bachelor’s or Master’s degree in a science-related field (e.g., BSN/RN, Pharmacy, PharmD) with 5+ years of pharmacovigilance experience.
-Experience in signal detection, safety surveillance, and risk management is a plus.
-Strong knowledge of FDA, EU, and ICH guidelines and regulations governing pharmacovigilance.
-Proficient in medical terminology and MedDRA.
-Excellent written and verbal communication skills.
-Capable of working independently and within a collaborative, fast-paced environment.
-Strong analytical, problem-solving, and adaptability skills.
-Effective planning, organization, and time management, with the ability to prioritize multiple projects.
What we offer:
As we work to develop innovations that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
· Full support and career-development resources to help you reach your potential
· A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Apply now and let's make work better!
www.biophaseinc.com
