Beschreibung
Pharmacovigilance Specialist - Bern, Switzerland
Skills:
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
Candidates with previous experience in biological products are favoured
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
Responsibilities -
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