Patient Safety Manager

Tasks and Responsibilities

Mainly: 

1. Operational support to clinical trial activities including but not limited to SAE management, reconciliation, unblinding activities as well as support in safety monitoring activities during development.
2. For clinical trials, responsible for management of Aggregate Reports (DSUR), and any other periodic reports required by regulators to ensure data completeness by the time of data lock point as well as providing tables and listings needed for the reports.
3. Revision of the synopsis, safety section of the protocols, safety section of the Data Management Plan, Safety Topics of Interest, and is accountable for the RSI of the study.
4. Lead the creation of the Safety Reporting Plan.
5. Active participation in the clinical study team meetings internal and with the CRO.
6. Operational support to non-interventional studies, market research, registries activities etc. including but not limited to ICSR management, reconciliation, as well as support in safety monitoring activities.
7. Post-marketing safety surveillance activities.
8. Supports the Patient Safety Director and EUQPPV to fulfil her internal duties as well as her responsibilities towards authorities.
9. Contributes to the establishment and performance of the Pharmacovigilance Quality Management System, and implements the procedures required by internal and applicable legislation.
10. Safety database tasks as applicable. 

Education

Science Degree. 

Relevant post-graduate training in pharmacovigilance and/or clinical safety and/or epidemiology preferred.

Specific Knowledge

Safety databases.

GVPs and other regulations as needed. 

Experience

Minimum 5 years of PV experience.

Clinical safety in a corporate safety department is appreciated.