Pharmacovigilance Manager - based in Belgium - Belgium

Based in Belgium and supporting a French Speaking client, our QPPV executes project related tasks and activities and will also delegate activities to other members for our client within the unit (PV specialist, PV associate, PV assistant) as and if required, and ensures a high quality of the services provided.  

What will be your key responsibilities:

Executes project tasks primarily specific to the unit, but also cross-functional, including without limitation Global ICSR processing, Global Literature monitoring.
Signal Management and Benefit Risk Management activities, Medicinal Product Management ( XEVMPD),Local project management(Local literature monitoring management, Local ICSR management, LPPV/LSO management.
Monthly reporting and compliance monitoring), Regulatory Intelligence, preparation and QC of pre-marketing and post-marketing aggregate reports (e.g. PSUR, DSUR, PBRER, PADER, etc.) Risk Management Plans(RMP), Study protocols , product documentation(SmPC, IB), Pharmacovigilance system master file (PSMF), performing the EU QPPV and deputy EUQPPV roles.
Oversight over the assigned Pharmacovigilance system(s), Management of project related PV contracts (PV service agreements, Safety data exchange agreements), Pharmacovigilance system master file management, EU QPPV EudraVigilance related activities.
Executes other project specific task as and if required.
Assign PV unit team members (PV specialist, PV associates, PV assistant) with project tasks and approach other unit team leads for resource allocation as and if required.
Act as escalation point for project team members (PV specialist, PV associates) for technical project issues, technical tasks and process issues or client complaints in relation to the project or technical work performed.
Escalate technical project issues further to the concerned unit team leads.
Involvement together with other team members in the scoping phase when and if required.
Support the PV Business Manager in proposal preparation as and if required.
Improvement of processes within the assigned Unit, ensuring a smooth run of the project, tasks and processes; ability to capture all running projects, tasks and processes within the unit and their relations to other units within the PV department.
Oversee the work performed by the project team members (PV specialists, PV associates, PV assistants) and ensure a high standard and quality of delivered work.

What experience should you have:

Bachelor’s degree or graduate in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences – advance degree (e.g. masters) preferable
minimum of 4 years of experience working in a medical or safety department with demonstrable expert knowledge of medical terminology
residency in Belgium
detailed knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS etc.)
experience working with a safety database desirable
knowledge of web-based communication tools for conferencing (Skype/Teams, WebEx, etc.)
fluent verbal and written in both English and French
ability to delegate and oversee work of junior staff
ability to provide training to junior staff
excellent team player, able to build an effective team
organizational and me-management skills, able to prioritize work and adhere to deadlines
excellent communication skills
maintains a positive, result oriented work environment