Abbott - Head - Pharmacovigilance

Key Responsibilities:

- Act as the company's SME for drug safety and pharmacovigilance, ensuring compliance with local and global PV regulations.

- Oversee PV contracts, vendor management, and PV system audits/inspections.

- Lead activities in signal management, benefit-risk evaluations, and safety data assessments.

- Develop and implement Risk Management Plans (RMPs) and additional risk mitigation strategies.

- Serve as the primary safety liaison with country regulatory authorities and internal stakeholders.

- Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance, and Marketing teams.

- Contribute to clinical trial safety strategies and documentation (protocols, safety monitoring plans, SAE reporting, etc.).

- Mentor, guide, and develop PV team members, fostering a culture of continuous improvement, compliance, and knowledge sharing.

- Manage departmental budgets, staffing, and resourcing in line with organizational needs.

Qualifications & Experience:

- Advanced degree in Medicine (MD) or Pharmacy (PharmD/MPharm).

- 10+ years of progressive pharmacovigilance experience within the pharmaceutical industry.

- Strong expertise in local and global PV regulations and guidelines.

- Demonstrated experience in leadership roles, with proven ability to build, scale, and optimize PV systems.

- Proficiency in signal detection, risk-benefit analysis, and RMP development.

- Excellent analytical, strategic thinking, leadership, and communication skills.