Senior Specialist, Drug Safety

About the role

The Senior Specialist, Drug Safety (Pharmacovigilance) is responsible for managing the company’s relationships with business development partners, third‑party vendors and emerging data sources. The role ensures all agreements, safety management plans and pharmacovigilance (PV) processes comply with global regulations.

Key responsibilities

• Provide subject‑matter expertise for PV templates and ensure compliance with global PV regulations.
• Organise and facilitate meetings with partners to negotiate, implement and maintain PV agreements, PV plans and safety management plans (SMPs).
• Lead due‑diligence, capability assessments and compliance reviews of partners and vendors.
• Maintain global PV standards and develop processes for high‑quality individual case and aggregate safety reporting.
• Create and deliver training on new PV processes and support inspections and audits related to partnerships.
• Collaborate with the system owner on the Business Development Lifecycle Management system.
• Participate in inter‑departmental meetings to integrate PV requirements into business processes and monitor quality issues.
• Support GCS&PV objectives and perform additional tasks as assigned by management.

Required profile

• Strong knowledge of pharmacovigilance principles and regulations.
• Excellent communication and interpersonal skills.
• Attention to detail and ability to manage competing priorities.
• Proven ability to independently manage projects to completion.
• Leadership experience across organisations.
• Bachelor’s degree in a technical, life‑science or related discipline.
• Minimum 2 years of pharmacovigilance or related experience.

Required skills