Oncology Safety & Pharmacovigilance Director

GSK

Durham (NC)

Hybrid

USD 170,000 - 283,000

Full time

5 days ago
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Benefits offered by this job

Health care
Retirement benefits
Paid holidays
Vacation
Parental leave
Paid caregiver leave

Job summary

GSK seeks a Senior Pharmacovigilance professional to lead safety governance and risk management across products in development and post‑marketing. You will drive safety strategy, oversee regulatory submissions, and collaborate with cross-functional teams to address product safety issues, ensuring patient safety and compliance.

The role requires 5+ years in PV, with strong knowledge of global regulations and signal detection.

Qualifications

  • Pharmacovigilance experience (5+ years) in pharma/biotech.
  • Experience with Signal Detection and safety surveillance.
  • Knowledge of international pharmacovigilance requirements (ICH, GVP modules) and drug development/approval.

Responsibilities

  • Leads safety governance by development of safety strategy for products in clinical development and post-marketing settings.
  • Leads the safety component of global regulatory submissions.
  • Represents GSK on cross-functional Clinical Matrix Teams and leads cross-functional ad hoc teams to address urgent safety issues.

Skills

Digital Fluency
Enterprise Leadership
Influencing Without Authority
Pharmacovigilance
Presentation Techniques

Education

PhD or equivalent in Life Sciences (preferred)
Bachelor’s degree in Life Sciences or Medical Sciences

Job description

GSK seeks a Senior Pharmacovigilance professional to lead safety governance and risk management across products in development and post‑marketing. You will drive safety strategy, oversee regulatory submissions, and collaborate with cross-functional teams to address product safety issues, ensuring patient safety and compliance.

The role requires 5+ years in PV, with strong knowledge of global regulations and signal detection.

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