Senior Pharmacovigilance Director

24 hours ago

California, United States BioPhase Full time

BioPhase Solutions is a leading recruitment agency specializing in placing top talent in the Life Sciences industry. We are currently seeking a highly skilled Contract Associate Director of Pharmacovigilance Sciences to join a prominent pharmaceutical company in Southern California.


Key Responsibilities:

  • Oversee all 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, such as DSUR and PBRER.
  • 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 to ensure timely and accurate submissions.
  • Conduct safety surveillance and signal detection activities for assigned products, identifying potential risks and developing mitigation strategies.
  • 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, ensuring compliance with regulatory requirements.
  • Participate in PV audits and regulatory inspections as a subject matter expert, providing valuable insights and recommendations.


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 highly desirable.

-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:

BioPhase Solutions is committed to providing a supportive and inclusive work environment that fosters professional growth and well-being. As a valued member of our team, you can expect:

· 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:

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