Associate Director of Pharmacovigilance Science

6 days ago

California, United States BioPhase Full time
Job Title: Associate Director of Pharmacovigilance Science

BioPhase Solutions is seeking a highly skilled Associate Director of Pharmacovigilance Science to join our team in Southern California. As a key member of our Life Sciences community, you will be responsible for managing pharmacovigilance activities for assigned products or therapeutic areas.

Key Responsibilities:
  • Pharmacovigilance Management: Oversee all pharmacovigilance activities, ensuring compliance with FDA, EU, and ICH guidelines and regulations.
  • Report Preparation: Prepare and submit pharmacovigilance aggregate reports, collaborating with safety physicians and stakeholders.
  • Safety Data Compilation: Compile safety data for regulatory submissions, post-marketing assessments, and label updates.
  • Team Leadership: Lead the review and approval process of pharmacovigilance reports, coordinating with safety physicians and external vendors.
  • Safety Surveillance: Conduct safety surveillance and signal detection activities for assigned products.
  • Team Collaboration: Organize and lead Safety Review Team (SRT) meetings, ensuring that all regulatory and Risk Management Plan (RMP) commitments are tracked and addressed.
  • Regulatory Compliance: Represent pharmacovigilance in clinical programs, collaborate with Regulatory Affairs on expedited safety reports, and support Drug Safety Monitoring Boards.
  • Vendor Oversight: Provide guidance and oversight to vendors supporting pharmacovigilance activities for investigational and marketed products.
  • Audit and Inspection Support: Participate in PV audits and regulatory inspections as a subject matter expert.

Requirements:

  • Education: Bachelor's or Master's degree in a science-related field (e.g., BSN/RN, Pharmacy, PharmD) with 5+ years of pharmacovigilance experience.
  • Experience: Experience in signal detection, safety surveillance, and risk management is a plus.
  • Skills: 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.

What We Offer:

  • Professional Growth: Full support and career-development resources to help you reach your potential.
  • Inclusive Community: A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.

Apply Now:

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