Senior Medical Advisor m/f – Global Pharmacovigilance Job in Ingelheim 55218, Rheinland
Are you seeking a new professional challenge and are you interested to work in an international team with attractive prospects at a pharmaceutical company which has achieved success at an international level and been named “best employer” several times?
Are you highly motivated and willing to assume full responsibility for the pharmacovigilance risk management activities of high profile and high priority marketed and/or investigational compounds?
If so, we can offer you the opportunity to use and advance your professional skills in a demanding international field of work.
Your tasks and responsibilities
- Develop proactive risk management strategies for key marketed and/
or investigational compounds
- Plan, manage / perform and monitor all pharmacovigilance activities
for assigned drug responsibilities, including:
- continuous monitoring and further development of the product safety profile
- safety issue management
- the set-up of safety analyses in both postmarketing and clinical trial databases
- close collaboration with Global Epidemiology and Medical Affairs on safety-focussed clinical and epidemiologic studies
- continuous monitoring and further development of the product safety profile
- Review and provide medical-scientific input to regulatory documents such as periodic safety and development safety update reports, risk management plans and clinical overview statements
- Chair the internal pharmacovigilance working group consisting of experts in Pharmacovigilance, Medical Affairs, Epidemiology and Biostatistics and other disciplines as appropriate
- Depending on the status of development of the compound and on personal capabilities lead, manage and medical-scientifically direct a team of pharmacovigilance physicians responsible for a product
- Provide updates of the assigned drugs safety profile to senior management and recommend pharmacovigilance / risk management activities to Boehringer Ingelheim decision making bodies and the EU QPPV
- Represent Global Pharmacovigilance in internal and external committees bodies
- Contribute to the further development of pharmacovigilance within our company by staying abreast of state of the art methodology, changes in the regulatory environment and developments and trends in healthcare system and society
You hold a Medical doctor with sound clinical experience and profound expertise in Pharmacovigilance and Risk Management in a major pharmaceutical company on a global / corporate level, including safety in clinical development and post-marketing safety. Board certification/experience in cardiology, metabolic disease management, hepatology, pulmonology, oncology would be an asset.
Very good and broad understanding of the pharmaceutical industry, and the future trends and developments in pharmacovigilance as well as thorough understanding of pharmacovigilance regulation in major markets and respective need for compliance are required.
As self-starter and driving personality you are characterised by leadership and project management competencies, excellent interpersonal and communication skills as well as your capacity for teamwork and highly ethical personality putting patient safety first.
Due to the international nature of the tasks your ability to work in multicultural and multidisciplinary teams and your fluency in spoken and written English are necessary, German language skills would be an asset.
You will be based in Ingelheim near Frankfurt, Germany.
We can offer stimulating career development with a suitable remuneration and benefits package.
If you are seeking opportunities to expand your professional horizon and your profile corresponds to the above, we would be delighted to hear from you.
For further information please contact Anne Renkes, phone +49 (0) 61 32 / 77 64 42.
As a company without barriers we welcome applications from people with disabilities if they have the relevant qualifications.
We look forward to receiving your online application - please enter
the reference code 4001 0386 GmbH 11/11 1.