Pharmacovigilance (PV) Specialist

• Qualified PV coverage and processes for back-up coverage (including coverage outside of business hours);
• Monitoring of Affiliate PV system performance and compliance, and resolving of nonconformities.
• PV training of the Affiliate staff and contractual partners;
• PV business continuity planning and notification of any incidents that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance;
• Participation in the internal PV audits and inspections from regulatory authorities;
• Individual Case Safety Report (ICSR) management and ICSRs received within the country(ies) covered by the country operation (receipt, documentation, tracking, expedited reporting, etc);
• Collection of safety data and other PV-related responsibilities in relation to interventional
• studies (clinical trials);
• Collection of safety data and other PV-related responsibilities in relation to organized data collection schemes (non-interventional studies, registries, patient support programs, market research programs, etc.);
• Local screening of scientific literature and social media for safety information;
• Periodic safety reporting (scheduling, local submissions, documentation etc.);
• Handling of inquiries relating to product safety including regulatory authority inquiries;
• Reconciliation of adverse events reports received from other operating units (e.g. Medical Information, product complaints) and contractual partners, as applicable
• Oversight of the Risk Management Plan (RMP) Implementation. Contribute to preparation of local RMP and ensure oversight of its implementation
• Contribution to product labeling changes;
• Review and approval of the safety sections/wording and processes in local commercial agreements to ensure appropriate training and reporting processes in accordance with company policies and local regulatory authority requirements
• Consideration of PV matters during locally performed due diligence activities and negotiated contractual agreements, and exchange of safety information as defined in safety data exchange agreements;
• Safety signaling activities;
• PSMF maintaining.

• University degree in Medical or Pharmaceutical
• Experience: at a minimum 1 years of pharmaceutical industry experience (preferably).
• Awareness of pharmacovigilance systems & requirements (preferably).
• Knowledge of the local country pharmacovigilance regulations & obligations (preferably).
• Strong communication skills.
• Efficient Computer Skills.
• Language proficiency: English upper-intermediate
• Excellent time management, organizational & planning skills.
• Strong project management skills with the ability to prioritize assignments.

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