Drug Safety Physician

ProClinical Ltd
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
ProClinical is seeking a Drug Safety Physician for a pharmaceutical company specialising in flu vaccines. This role with be based in Maidenhead on a permanent basis.

Role Overview:

* The Benefit-Risk Management Physician (also generally to as safety physician) is responsible for the medical expertise on all aspects of safety throughout the entire lifecycle of the assigned company product(s).
* The BRMP will apply sound medical judgment for the analysis and interpretation of complex data for signal detection, substantiation and initiation of safety risk management activities including and not limited to risk minimization activities (studies, registries, real world databases) and evaluation of the effectiveness of risk mitigation measures.
* The role integrates these safety risk management activities of a given product, into the regulatory and business context.
* He/she ensures the development and implementation of the safety strategy for company products throughout their entire lifecycle that is compliant with international Pharmacovigilance regulatory requirements while also ensuring company strategy is delivered.
* The BRMP must have expert scientific and medical knowledge of company therapeutic area and international standards and expectations, including and not limited to Good Vigilance Practice as defined by the EMA.
* The BRMP will apply sound medical judgement for analysis and interpretation of complex safety data for signal detection/substantiation and initiation of safety risk management activities including safety specification, PV planning, risk minimization/mitigation and evaluation of effectiveness of risk mitigation measures.
* The role ensures the integration of benefit risk management tools/expertise into a medical, business or regulatory context of the products.
* The BRMP brings her/his expertise and represents Pharmacovigilance in the cross-functional clinical development meetings.
* Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of single and/or aggregate safety data and literature during all phases of the life cycle of a defined portfolio of medicinal products.

Skills and Requirements:

* 5 to 7 years of experience in Benefit-Risk Management and Clinical Trial Safety is required, in all aspects of Benefit-Risk Management (risk identification; risk assessment; risk communication; risk mitigation; evaluation of risk mitigation).
* Exposure to Clinical Development and/or clinical safety of at least 1 product submitted to Regulatory Authorities for marketing authorization.
* Expert in the Safety Regulations with comprehensive knowledge of global drug/vaccines safety regulations, guidances (including European GVP) and best practices.
* Understanding of current approaches to balancing the benefits and risks of company products, in particular, experience developing and implementing a risk management plan acceptable to FDA and EMEA.
* Familiarity with cross functional principles of drug development, pharmacology, biostatistics, clinical trial methodology, pharmacoepidemiology, medical safety and pharmacovigilance. Sound clinical acumen and in depth therapeutic area/product knowledge and able to assess, manage and communicate appropriately with respect to the safety profile of medicinal products
* Strong communicator with excellent English language skills, both written and spoken, ideally with demonstrable experience in medical and scientific writing
* Good networking and team skills for successful cooperation with internal and external customers
* Self-confident, proactive and decisive
* Excellent communication skills, including formal presentation skills.
* Ability to thrive in a global, matrix environment as a team player.
* Ability to successfully manage and prioritize multiple critical issues simultaneously.
* Previous practice of medicine

To Apply:

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 call Jon Stewart on Phone number removed or upload your CV on our website - URL removed
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.