Pharmacovigilance Officer

Role Overview

This is a leadership position accountable for the end-to-end pharmacovigilance operation: capturing every suspected adverse reaction that reaches the business, evaluating and submitting individual cases on time, and keeping the safety database, master files and risk management documentation inspection-ready. Day to day the role balances hands-on technical PV work — case processing, literature review, periodic reporting, health authority correspondence — with the relationship and people responsibilities that keep the function credible, including partner agreements, global alignment and management of the drug safety team itself. It matters because the employer's licence to market depends on a demonstrably compliant, consistent and well-trained safety system that regulators, partners and internal stakeholders can all rely on.

Key Responsibilities

• Own and maintain a single-point collection system so that all suspected adverse reaction reports — including those originating from medical representatives and clinical research associates — are captured, collated and routed without gaps.
• Evaluate, process and submit Individual Case Safety Reports (ICSRs) in line with applicable reporting timelines and quality standards.
• Prepare and submit Periodic Safety Update Reports (PSURs) as required, and manage the lifecycle of Risk Management Plans (RMPs), including updates as new information emerges.
• Negotiate, implement and maintain Safety Data Exchange Agreements (SDEAs) with partners, and keep the Drug Safety System Database and Master Files current, including reconciliation of data with third parties.
• Run the required literature searches, respond to Health Authority safety queries concerning company products, and contribute the safety input to Annual Product Quality Reviews (APQRs).
• Build and manage relationships with business partners in line with PVA and SDEA obligations, align with the global drug safety organisation, and maintain a credible, constructive profile with regulatory authorities and industry bodies.
• Work cross-functionally to define how the safety function best serves the wider business, track stakeholder satisfaction and performance against agreed SLAs, and drive identified improvements.
• Lead the drug safety team: recruit appropriately skilled people, deliver and assess training (including PV induction for new staff), keep competence records, organograms and job descriptions current, set SMART objectives for performance purposes, and manage individual performance and career development in line with HR policy and in partnership with the VP, Head of Quality.

Requirements & Qualifications

• Degree-level qualification in pharmacy, medicine, nursing, life sciences or a closely related discipline; a postgraduate qualification or formal pharmacovigilance certification is an advantage.
• Substantial, progressive experience in pharmacovigilance or drug safety, including a track record of leading or supervising a safety team and of taking accountability for compliance outcomes rather than only executing tasks.
• Practical command of the core PV deliverables: ICSR triage, assessment, follow-up and submission; PSUR/PBRER authoring; RMP development and maintenance; and SDEA negotiation and management.
• Working knowledge of the regulatory frameworks governing drug safety in the jurisdictions covered, including ICH guidelines and relevant local legislation, plus familiarity with MedDRA coding and a safety database (for example Argus or an equivalent system).
• Confidence in handling health authority safety queries, representing the company in partner and regulator discussions, and contributing to audits and inspections.
• Strong written precision and analytical judgement, since case narratives, aggregate reports and correspondence with regulators must withstand professional and regulatory scrutiny.
• Demonstrated people skills across the full management cycle: recruitment, training and competency assessment, objective setting, performance feedback and career development.
• Proven ability to work across functions and geographies, hold partners to contractual safety obligations, and balance competing stakeholder priorities while protecting compliance.