The PV -Quality Officer (Deputy NPPV) – supports the NPPV in the end-to-end oversight of the local pharmacovigilance system. The role contributes to ensuring affiliate compliance with PV legislation, including oversight of case intake and reporting, local literature surveillance, implementation of risk minimisation measures and safety communications, maintenance of PSMF annexes, vendor and partner oversight, inspection and audit readiness, and delivery of PV training to affiliate staff.
In addition, the PV – Quality Officer supports the ALK Benelux Quality System in compliance with local legislation and global procedures, including maintaining procedure distribution and updating local quality documentation. Contributes to the implementation of global quality standards and provides support on GDPR-related activities. Ensures ongoing awareness of EU and Benelux quality and GDPR requirements while supporting broader quality tasks as needed.
The position is based in the Netherlands, requires fluency in Dutch (C2) and English.
Key Responsibilities The Pharmacovigilance Officer responsibilities- Recording, processing, evaluation and follow-up (obtaining further information) of drug risks such as side effects and pharmaceutical-technical complaints from The Netherlands, Belgium and Luxemburg.
- Support of the Nationally responsible person for pharmacovigilance (NPPV) in the tasks for The Netherlands, Belgium, and Luxemburg (e.g., market research projects, social media projects, investigator-initiated trials, non-interventional studies, Implementation of PV Agreements and trainings for external business partners, revision of SOPs).
- Support in case of audit(s) of internal and external vendors.
- Maintaining a local PV system in collaboration with PV staff.
- Maintain the original single case files at the affiliate according to local SOPs and provide paper files for Adverse Drug Reactions (ADR) reports to GSP upon request.
- Collect single cases (ADRs, solicited reports, complaints etc. As described in previous sections).
- Maintaining the PV tracking system of collected and potential ADRs at affiliate.
- Requesting additional information from reporter (e.g., the Health Care Provider or Consumer) of Individual Case Safety Reports (ICSR) if requested from GSP for assessment of cases.
- Archiving PV related documentation according to the local archiving SOP.
- Assist the NPPV with PV trainings for all internal stakeholders to ensure staff are trained in how, where and when to report ICRRs.
- Support the ALK Benelux quality system in accordance with Benelux legislation and within the framework of local and company-wide procedures.
- Support the maintenance of a matrix to ensure that new or updated local or company-wide procedures reach the right people within ALK Benelux.
- Write/Update/Review Local Quality procedures and implement Global Quality Procedures Local.
- Support Data Protection Local Representatives with GDPR.
- Additional Quality tasks:
- Keep up to date with EU, BE, LUX and NL legislation and guidance Quality and GDPR.
- Support Quality where necessary.
- Relevant education and broad experience within medical or pharmacy, Bachelor or Master degree.
- Minimum of 2 years' experience in pharmaceutical company within the areas of PV, clinical, and/or Quality, international company experience is preferred.
- Thorough theoretical, practical knowledge with local PV Regulation, guidelines and ICH guidelines.
- Fluency in spoken as well as written Dutch (C2) and English.
- Effective communication skills, specifically oral and written presentation skills.
- Knowledge of GDPR and GxP is a plus.
- Result driven and eager to learn & work precisely and accurately.
- Ability to work both independently and within a team.
€50000 - €75000 monthly