
Drug Safety Expert
2 days ago
Drug Safety Expert - Pharmacovigilance Lead
Key Responsibilities:
- Serve as the company's subject matter expert on drug safety and pharmacovigilance, ensuring compliance with Local & Global PV-relevant Heath Authority requirements.
- Oversee pharmacovigilance contracts, vendor management, and system audits/inspections, demonstrating good understanding of signal management and benefit-risk evaluation activities.
- Develop and implement Risk Management Plans (RMPs) and additional risk mitigation measures, collaborating with country regulatory authorities and internal stakeholders.
- Contribute to clinical trial safety strategies and protocols, mentoring and developing PV team members to maintain a culture of continuous improvement and compliance.
Requirements:
- Advanced degree in Medicine or Pharmacy, with minimum 10 years of progressive pharmacovigilance experience in the pharmaceutical industry.
- In-depth understanding of Local/global PV regulations and guidance, with demonstrated experience in leadership roles and proven ability to build and scale PV systems.
- Strong analytical, strategic thinking, and communication skills are essential for this role.
Benefits:
This is an exciting opportunity to work in a dynamic environment, driving pharmacovigilance excellence and contributing to the development of innovative medicines. The successful candidate will have the chance to collaborate with cross-functional teams, develop their skills, and take on new challenges in a supportive and inclusive work environment.
Other Information:
The ideal candidate will possess a strong track record of delivering high-quality results, with excellent problem-solving skills and the ability to work effectively in a fast-paced environment.
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