Pharmacovigilance and Quality Associate

Dear freelancer, For one of our clients, a biosimilar company we are looking for an Pharmacovigilance and Quality Associate. The Pharmacovigilance and Quality Associate will actively support the responsible pharmacist of the company in all the Pharmacovigilance and Quality Assurance tasks and activities. DESCRIPTION Pharmacovigilance and Safety: In collaboration with the local contact person for PV, on-going development and maintenance of the local PV database and support systems. Maintain awareness of current safety considerations regarding the products in the Benelux. Support on receipt and handling of ADR/AE/Pregnancy reports/Quality Defect or similar Support in Product Withdrawal, or Product Recall Ensure requests from competent authorities are adequately and timely being addressed. Receipt and management of medical device/pharma product complaints in BNL and daily KPI reports Maintenance of the Complaint tracking sheet according to local SOPs Attend monthly PV meeting with affiliates and EU QPPV Literature review at least once per week and ensure quality control is obtained of Dutch to English translated reports. Follow-up on local regulations and guidelines. Quality Assurance: Ensure inspection readiness by maintaining and improving the quality system Ensure in time review + coordinate writing of SOPs, work instructions and forms Ensure relevant Benelux personnel is aware of SOP changes Initiate and follow up of exception reports/CAPA when applicable in trackwise GEMS Attend monthly QA meeting with affiliates and QA EMEA Administrative control of Imported products Handling of field actions, quality holds and outbound temperature excursions according to SOPs Execute Benelux internal audits Prepare and participate in Benelux audits and inspections, and ensure adequate response and follow-up is given to audit and inspection findings. Follow-up on local regulations and guidelines In collaboration with relevant parties and departments ensure that RA/Quality/ PV obligations are adequately and clearly specified in contractual agreements. Ensure that such contractual agreements with other parties are communicated to the competent authority. Involvement in due diligence of potential new product acquisitions. PROFILE Scientific background (pharmacy, chemical, biology,???) is essential Pharmacist is a plus Fluent in Dutch and English 3-5 years industry experience in QA Strong knowledge of local pharmaceutical regulations Pharmacovigilance experience is a plus Self-motivated Ability to work with others as well as independently Admin and organizational skills OFFER A job in a dynamic work environment and a competitive remuneration package according to your experience.