Beschreibung
Pharmocovigilance Technician
CHF Negotiable
Bern, Switzerland
6 month contract
The responsibilities of this position include:
Work in partnership with Pharmacovigilance Experts (Physicians and Scientists) for various Pharmacovigilance activities:
* Validation and assessment of safety observation and safety signals and identification of potential impact on patient safety.
* Writing of ad hoc safety reviews and benefit & risk assessment for safety signals.
* Coordination and writing of PSURs, Risk Management Plans, DSUR safety sections and other PV-related documents
* Preparation of responses to Health Authorities safety-related questions
* Preparation of medical safety sections in clinical protocols, investigators brochures and other study-related documents
* Support to Safety Management Team (SMT) Chairs in the organization and running of SMT for individual products in the marketing phase and in clinical development
* Contribution/Lead in Health Hazard Evaluations in case of Product Technical Complaints
Contribution to review and establishment of global PV processes
What we require from the candidate:
* Person with in depth experience in multiple areas of Pharmacovigilance ranging from medical assessment and benefit-risk analyses to PV operation activities.
* Up to date knowledge in main PV regulations world wide
* Capacity to work "Hands on" and independently, with good project management skills
* Able to deliver
* Candidates with previous experience in biological products are favoured
* Experience: min 5+ years
Language: English - fluent