Herakles is looking for a Drug Safety and Medical Information Officer for a leading, research-oriented and pharmaceutical company.
You are responsible for executing pharmacovigilance (PV) processes to continuously ensure compliance with global and local regulatory requirements and the global requirements within our client in the Netherlands. Also you are responsible for correct, timely and customer-oriented response to medical questions from internal and external stakeholders, in such a way that the integrity of our client in the Netherlands will be safeguarded.
Main responsibilities for the function as a Drug Safety and Medical Information Officer:
- Ensure that all incoming safety information is assessed and forwarded to the PV hub within the established timelines;
- Act upon individual case safety report (ICSR) follow-up requests and safety queries;
- Answer safety related questions from internal and external stakeholders;
- Receive and triage all internal and external medical enquiries (e.g. from physicians, pharmacists,nurses and patients);
- Provide scientific,unbiased, balanced, up to date, timely and customer-oriented response to medical enquiries. If necessary, forward medical enquiries to relevant colleagues for processing (including safety cases). Accurately document enquiries in the medical enquiry database;
- Maintain an out of business hours call service on rotational basis for emergency requests in the evenings and weekends (pharmacovigilance requirement);
To be succesfull in this Drug Safety role we expect that you have at least two years of experience in in the pharmaceutical industry, preferably in a similar role.
As important as experience is that you recognize yourself in the following:
- MSc (life sciences/health sciences degree) or equivalent;
- Thorough knowledge of both English and Dutch language;
- Knowledge of GVP regulations is desirable.
This position is a contracting role through Herakles for initially 6 months. Thereafter it is likely that you will be hired by our client.
Interested in this role as Drug Safety and Medical Information Expert? Please apply through this website. If you have any questions, please reach out to the person mentioned below.
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