Job description - Drug Safety Officer
Alternative job titles
Pharmacovigilance Associate Drug Safety Associate
Pharmacovigilance Officer
Description
The Drug Safety Officer is responsible for collecting, monitoring, processing, and distributing 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.
Qualifications
A candidate for Drug Safety Officer should possess qualifications in a biomedical science, pharmacy, health sciences or medical biology. The candidate should possess a good understanding of normal and pathological physiological function and have experience with product-oriented contact with doctors and patients. Professional use of the English language; both written and verbal.
Competencies
- Recognise potential obstacles and work to resolve them within set timelines
- Work precisely according to procedures, rules and regulations
- Approach issues from a number of perspectives, summarising data to draw a conclusion
Tasks
- 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
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