As the Pharmacovigilance (PV) Specialist, you’ll have the chance to be responsible for the day-to-day coordination of activities, related to the safety aspects of Abbott pharmaceutical products within the country(ies) covered by the country operation including compliance with PV processes and regulations and company policies and procedures.

Acts as local PV point of contact person (local QPPV) for the national Health Authority as legally required.

What You’ll Do

• 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.

Background Requirements

• 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.