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A leading company in the pharmaceutical sector is seeking a Safety Lead responsible for pharmacovigilance activities to ensure compliance with regulations. The role focuses on management and oversight of local PV operations, coaching staff, and maintaining effective risk management systems. Candidates should have a degree in Health Care Science and significant experience in pharmacovigilance.
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The Safety Lead is responsible for ensuring that all pharmacovigilance (PV) activities within the Local Operating Company (LOC) comply with local regulations and company policies at local, regional, and global levels. This includes oversight of activities aligned with product vigilance agreements (PVAs) with third-party partners. The Safety Lead may serve as the primary PV contact for the local health authority and is accountable for establishing and maintaining effective PV and risk management systems across assigned territories.
Key Responsibilities:
·Ensuring daily PV operations and regulatory compliance at the local level.
·Acting as delegate for the Regional Safety Head when needed.
·Overseeing and coaching local PV staff or vendors.
·Supporting inspection readiness and leading audits/inspections locally.
·Managing local safety processes, PSMF input, AE reporting, and CAPA development.
·Advising local business on PV impact of programs and regulatory changes.
·Ensuring local implementation of global PV procedures and training.
·Monitoring changes in local PV legislation and ensuring compliance.
Role Qualifications:
Expected Skills:
·Strong analytical and problem-solving skills, with high attention to detail.
·Excellent organizational abilities; capable of managing multiple priorities effectively.
·In-depth understanding of pharmacovigilance, drug development, and pharmacology principles.
·Proven experience in line management and vendor oversight.
·Expert knowledge of relevant global, regional, and local PV procedures.
·Strong communication and negotiation skills with both internal and external stakeholders.
·Ability to build and maintain effective relationships with regulatory authorities and cross-functional teams.
·Solid understanding of local and global product safety requirements.