Associate Director, Safety Physician
ProClinical is seeking an Associate Director, Safety Physician on behalf of an innovative Japanese pharmaceutical company. The company develops medicines for patients in the areas of CNS, oncology, endocrinology and many more. This is a permanent position based in Frankfurt, Germany.
- Acts as a safety officer within the global PV team for the assigned therapeutic areas.
- Contributes to aggregated reports, risk management plans and risk minimization activities, conducts medical reviews of individual safety reports, participates in signal detection activities, contributes to applications for marketing authorization and to respond to requests from health authorities.
- With a team on different continents, this is a highly international position and therefore requires some international travel (about 10%).
- An opportunity to develop a deep understanding of EU PV legislation and become an expert in pharmacovigilance
- Participate in the implementation of pharmacovigilance for assigned products or projects, including medical assessments, ongoing safety assessment and signal recognition within the Global Pharmacovigilance Organization
- Contribution to and review of key pharmacovigilance documents such as PSURs, CCSIs, risk management plans, security sections of SmPCs , IBs, protocols for clinical studies / studies and final reports
- Participates in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable
- On assignment: Training of company personnel, Contract Research Organisations, and investigational site personnel regarding Pharmacovigilance related issues
- Requires a true team player with strong communication skills and a sense for cultural differences.
- The ideal candidate has an interest in continuous learning, is flexible and open to different opinions, but also has compelling skills.
- Fluency in English and German
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Andreas Barteit at email@example.com or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
A Swiss-based global biopharmaceutical company that specialises in the development and manufacture of drugs and diagnostics tools is seeking to recruit a Clinical Safety Physician.