Job description - Drug Safety Manager
Alternative job titles
Pharmacovigilance Manager Drug Safety Executive
Pharmacovigilance Executive
Description
The Drug Safety Manager is responsible for the Drug Safety department and staff, which is in turn responsible for the collection, monitoring, processing, and distribution of adverse event reports and information queries for investigational and marketed products. He/she is also responsible for safety and medical information for the assigned products, including safety components of protocols and studies for assigned drugs. The position of Drug Safety Manager can be segregated into two levels, first being to notice and report side-effects and secondly to analyse the side-effects to improve clinical research within the company.
Qualifications
A candidate for Drug Safety Manager should possess extensive experience as a Drug Safety Officer. Professional use of the English language; both written and verbal.
Competencies
- Make strategic decisions
- Recognise potential obstacles and work to resolve them within set timelines
- Analytical expertise in understanding complex issues and their consequences
Tasks
- Manage the handling and reporting of all pharmacovigilance related matters used in clinical trials, compassionate use programs and for marketed products
- Act as the internal safety resource in connection with safety issues
- Support other departments in safety issues, i.e. participate in the preparation of local informed consent and 'safety-sections' of development protocols
- Active involvement in internal and external developments through close internal interactions and through participation in external safety meetings and assessment of external national safety information
- Develop and execute training programs for personnel
- Obtain and verify new information concerning pharmacovigilance
Back