Pharmacovigilance Officer

Permanent
- Pharmaceutical
- As a (Deputy) EU Qualified Person for Pharmacovigilance (EU QPPV) and (Deputy) Local Contact Person (LCP) you are responsible for detecting, assessing, monitoring and acting preventively on side effects of pharmaceutical products and for reducing the risk of any harm to patients.

**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 mínimal 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.
- Preferably, a first relevant work experience in Regulatory Affairs.