Senior Specialist, Drug Safety (Pharmacovigilance)

About the role

The Senior Specialist, Drug Safety (Pharmacovigilance) leads the management of the company’s relationships with business development partners, third‑party vendors and emerging data sources. Reporting to the Executive Director of Pharmacovigilance Partner Strategy & Management, the role ensures all safety agreements, plans and management processes comply with global PV regulations.

Key responsibilities

• Contribute subject‑matter expertise to PV templates for partners, vendors and emerging data source deals.
• Organise and facilitate meetings with partners, CROs, vendors and internal stakeholders 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 to ensure compliance and quality of safety requirements.
• Develop and maintain processes for high‑quality individual case and aggregate safety reporting.
• Create and deliver training on new PV processes and agreements.
• Support inspections and audits related to company partnerships.
• Collaborate with system owners on the Business Development Lifecycle Management system.
• Participate in inter‑departmental meetings to integrate PV requirements into business processes.
• Identify, prioritize and monitor quality issues to maintain compliance.
• Develop and support processes that achieve GCS & PV objectives.

Required profile

• BS degree in a technical discipline (science, engineering) or life sciences (biology, chemistry, nursing, pharmacy) or related field.
• Minimum 2 years of pharmacovigilance or related experience.
• Strong knowledge of pharmacovigilance principles and global regulations.
• Excellent communication and interpersonal skills.
• Ability to manage projects independently and drive them to completion.
• Attention to detail and flexibility to meet competing daily priorities.

Required skills