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Vacancy information
Ensure the planning and realization of pharmaceutical activities in line with established procedures (SOPs).
Developing good contacts with customers where professionalism, image and impeccable quality are guaranteed.
- Creation and maintenance of a pharmacovigilance system, Pharmacovigilance System Master File (PSMF).
- Carry out continuous evaluation of the benefit/risk profile of medicines.
- Report adverse reactions, Individual Case Safety reports (ICSRs) to EudraVigilance.
- Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) management and update.
- Delivering the medical documentation (Medical Writing) for medicines.
- Create PV (Medical Writing) procedures for clients that are in line with guidelines so that a minimal pharmacovigilance system is in place.
- Prepare PSURs (Periodic Safety Update Reports) including Medical Writing that provide an update of the safety of a medicine after an analysis of the benefits and risks during the post-authorisation period.
- Perform global literature screening of published medical and scientific literature on a weekly basis, so that any mention of side effects or special situations of medicines is timely noticed and processed according to the PV quality system.
- Ensure that written contracts are in place with other companies (incl. partners, service providers, and other third parties) regarding pharmacovigilance.
- Provide communication with the competent authorities regarding pharmacovigilance (PV).
Requirements information
REQUIRED COMPETENCES:
Customer orientation: Investigating the wishes and needs of the customer and acting accordingly. Anticipating customer needs. Giving high priority to service willingness and customer satisfaction.
Collaboration/Collegiality: Making an active contribution to a joint result or problem solution. Collaborating means thinking and cooperating with the other(s), making an effort to achieve the joint result.
Organizational: Determining goals and priorities in an effective way and indicating the time, actions and resources required to achieve certain goals.
Self-development: Having insight into your own strengths and weaknesses. Based on this, take actions to increase/improve own knowledge, skills and competencies and thus perform better.
Quality-oriented/accuracy: carrying out, checking work carefully and completely, using checklists where possible to ensure that no errors or omissions remain undetected.
EDUCATION / EXPERIENCE:
Master of Life Sciences, preferably M.Sc. Pharmacy
Strong communication skills (DU/ENG/FR)
Affinity with European legislation and regulations for medicines and health products.
