Director of Pharmacovigilance Operations

3 weeks ago

California, United States BioPhase Full time
Pharmacovigilance Expert Wanted

BioPhase Solutions is seeking a highly skilled Pharmacovigilance expert to join our team. As a leading recruitment agency for the Life Sciences industry, we are committed to finding top talent for our clients.

Key Responsibilities:

  • Oversee pharmacovigilance activities for assigned products or therapeutic areas, ensuring compliance with regulatory requirements.
  • Collaborate with safety physicians and stakeholders to prepare and submit pharmacovigilance aggregate reports.
  • Compile safety data for regulatory submissions, post-marketing assessments, and label updates, utilizing strong analytical and problem-solving skills.
  • 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, staying up-to-date with industry developments and guidelines.
  • 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, utilizing strong communication and interpersonal skills.

Requirements:

  • 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:

At BioPhase Solutions, we are committed to supporting the growth and well-being of our team members. We offer a diverse and inclusive community, where professionals are empowered to bring ideas to the table and act. Apply now and let's work together to make a difference in the Life Sciences industry.

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