Pharmacovigilance Physician - Germany

Reference No: J5754

Pharmacovigilance Physician Job - Germany

A rapidly-growing, global pharmaceutical company, recognised for having strong patent protection and a good pipeline of compounds, is looking to add additional skills to the Pharmacovigilance team within its German affiliate.

Role description:

The Senior Pharmacovigilance Physician will report to and assist the Head of Pharmacovigilance in the safety assessment of assigned drugs that are marketed and/or in clinical development. The successful candidate will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products. You will help ensure communication of potential and known risks, when appropriate, to various functions and colleagues internally and regulatory bodies and patients externally. In compliance with legal and regulatory requirements, the Senior Pharmacovigilance Physician will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of company pharmaceutical products.

Required technical knowledge and skills:

•Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications
•Experience and knowledge of Good Clinical Practice and Pharmacovigilance regulatory requirements in Germany and the EU, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans
•Able to plan work to meet deadlines and effectively handle multiple priorities
•Fluent in written / spoken English and German (written skills evidenced by publication and journal articles if possible)

Education and Experience:

•Demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations
•Ability to influence, negotiate and communicate with both internal and external customer. Previous clinical development experience is important to enable strong engagement with those currently running clinical trial studies
- Qualified Physician with significant post-qualification clinical and drug safety experience
- Motivated and enthusiastic about drug safety

Salary & Benefits:

A competitive basic salary and benefits including car/allowance, bonus, pension, health cover, and life assurance.

To apply:

If this role is of interest please email spencer@onlymedics.com.

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