Pharmacovigilance Manager

Do something that moves you.

Case Management activities
Handles all matters regarding AE/PTC handling in the PV team relating (but not limited) to:

// Responsible for case receipt, translation related activities and transfer to SDRA where applicable. Identifies cases where missing or unclear information is provided and performs clarification as needed with reporter.

// Performs follow-up activities of ICSRs in a timely manner.

// Responsible for reconciliation of cases with external partners and liaises with PVRC, as applicable.

// Performs the submission of the ICSRs to HA in accordance with the national regulations.

// Liaises with the Quality Representative (QR) in relation to AE reports associated with Product Technical Complaint (PTC) and aligns on actions.

Process Management activities
Executes a high-quality oversight of local PV process and compliance management by:

// Monitoring of local PV regulation and QSD management in relation to global process descriptions and the EU-PSMF and maintenance of the local PSMF.

// Assisting with local PV CAPA management activities.

// Overviewing PV quality of various programs and projects initiated by internal stakeholders as delegated by PVCH.

// Actively contributing to audits, inspections, and contract management.

// Being involved in the preparation of the PV training given to the local/ cluster organization (schedule, training material, organization). When indicated by the PVCH, the PV Manager completely takes over the PV training.

// Conducting the local literature search for AEs as well as the routine testing of PV systems.

Safety Management activities
Supports handling of local safety topics and issues and contributes to appropriate use of Bayer’s products by:

// Contributing to the handling and generation of aggregate reports and SUSAR/line listings reporting to National Competent Authority, relevant ethics committees and investigators in the country, where applicable.

// Having an active role in local safety issue management activities (including LSMT) as requested by the PVCH.

// Actively contributing to Risk Management Plan activities, which may involve developing and implementing additional local risk minimization measures, with other stakeholders, where applicable.

// The PV Manager supports the PVCH in the provision of safety input into clinical, medical and commercial studies and projects.

Unlock your potentials.

// Education: Medical doctor or pharmacist 

// Serbian residency

// Experience in pharmacovigilance activities minimum 3 years

// Good knowledge of medical terminology

// Detail-minded and task-oriented person

// Ability to adhere to procedures

// Written and verbal communication skills in Serbian and English

// Excellent administrative skills

// Good computer knowledge

// Strong sense of responsibility and conscientiousness, priority setting, organizing and able to multi-task effectively

// Stress resistance and ability to comply with strict deadlines

What we offer:

// Good working conditions

// Competitive salary

// Additional benefits according to performance

// Full time employment

Be part of something bigger.

If you believe you are the right person for this position, please send your application letter and CV in English language electronically.