Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per Abbott’s procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements.
Responsible for the reconciliation of adverse events reports received from other Abbott operating units (e.g., Quality Department, Medical Affairs, etc.) and contractual partners, as applicable
Responsible for the filing, storage and archiving of safety-related data in accordance with Abbott’s policies and local requirements.
Serve as the local Deputy Qualified Person for PV (QPPV) / deputy local responsible PV person for the country(ies) when delegated by PV Manager.
Serve as back-up in the absence of the PV Manager to ensure business continuity.
Responsible for being compliant with local PV regulations, Abbott policies and procedures and Global Safety procedures at the country level.
Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
Coordinate the development local Third Party Agreements with PV implications. Review local service provider agreements, co-distribution, co-marketing, in-licensing contracts to ensure PV roles and responsibilities are defined. Ensure the SDEAs are implemented locally, in close cooperation with the GPV.
Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
Identify and communicate potential safety issues to PV Manager.
Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.
Complete and document required PV training within the required timelines.
Perform other activities as requested by the PV Manager.
З/п обсуждается индивидуально с успешными кандидатами
Полный соц. пакет
University degree in Medicine or Pharmacy
High level of responsibility
Presentation and negotiation skills
Upper Intermediate in English
Experience in the position of pharmacovigilance specialist for at least 2 years.