Pv Physician

il y a 6 jours


Leuven, Belgique BioTalent Temps plein

Drug Safety Physician - Remote - Full time - permanent

Senior/Drug Safety Physician to join a leading Global Clinical Stage Drug Safety Consultancy.

The main purpose of this role is to engage in Drug Safety / clinical trial technical activities, working cross functionally to provide medical support within the Pharmacovigilance vertical. You will be involved in continuous safety assessment, evaluation and risk management acting as a marketing authorisation holder for clients.

**Offer**:

- Permanent position
- Fully remote position
- Full time and part time options available
- Working with a variety of Big Pharma and BioTech organisations

**Requirements**:

- Medically qualified Doctor
- 2+ years patient facing role / clinical practice
- Practical experience of PV/Safety processes, directives, regulations and guidelines.
- Working to high standards, autonomously, within scope of expertise (happy to ask for support and learn when needed)

**Must be living in EU or Switzerland and authorised to work in EU or Switzerland.**

Responsibilities/Activities:

- AE/SAE/SUSARs/SADRs (including clinical trials), medical support to QPPV and colleagues, benefit-risk of medicinal products, CCDs/SmPC/PIL, ICSRs, signal detection/management, medical input to PSUR/DSUR/RMPs/clinical trial documentation, GPVP, LPPV/LSO management, SDEA, PVA, reconciliation etc