Hobson Prior is working with a global pharmaceutical company, with over 100 years of scientific expertise and a presence in more than 20 countries, is seeking a Drug Safety Physician to be based in Germany on a permanent basis.
- Responsible for safety activities for new oncology products
- Preparation of submission documents for marketing authorization applications (MAA) for oncology products requested by European authorities
- Supervision and provision of answers to outstanding authority questions during MAA
- Performs triage of incoming cases of Individual Case Safety Reports (ICSRs) and clinical trial serious adverse events, generates narratives including medical evaluation and generation of company comment
- Generates and ensures timely submission of Periodic Safety Update Reports (PSURs) Development Safety Update Reports (DSURs), Risk Management Plans (RMPs) and Signal Detection Reports
- On-going pharmacovigilance evaluation for medicinal products and creation of response documents for health authority requests
- Medical-scientific analysis of clinical trials, Post Authorisation Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects
- Creation and maintenance of Standard Operating Procedures (SOPs) within Clinical Safety & Pharmacovigilance department
- Contribution to maintenance of pharmacovigilance quality management system
- Review of study synopses/protocols, investigators brochures, study reports and regulatory documents
- Contribution and support of Regulatory Affairs department concerning creation of regulatory documents
- Member of global project groups
- Experience in the oncological field for at least of 2 years
- Ability to interact target-aimed internally as well as externally to support a global business strategy
- Very good knowledge of database and coding systems and strong analytical skills
- Personal integrity and high degree of confidentiality
- Ability to handle and prioritize multiple complex projects and tasks simultaneously and to work independently
- Good knowledge of MS Office
- Medical degree as well as an approbation as physician
- Minimum of 2 years of relevant experience in a similar position within the pharmaceutical industry
- Fluent in English and German, both in oral and written communication
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life science recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.