Head of Safety Evaluation & International PV

A leading pharmaceutical client is searching for a Head of Safety Evaluation & International PV to join their team in Hertfordshire. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe. This role will lead and direct the team of Global Drug Safety physicians and scientists based in EKC responsible for global safety evaluation and risk management of selected company products (clinical development and marketed) and EMEA regional products

Job Responsibilities:

• Lead and manage the team of physicians (GSOs) and scientists responsible for signal detection and evaluation and the ongoing safety monitoring of a group of company products, as assigned by the Global Safety Board Chair
• Ensure that all signal management activities and benefit-risk analyses are conducted, and aggregate safety reports are produced in accordance with regulatory requirements, company standards and operating procedures and within required timelines
• Provide mentorship, training and support to direct reports in signal management/ safety evaluation
• Lead and ensure the provision of responses to safety-related medical queries from regulatory authorities, external bodies and internally for specified products.
• Act as General Safety Officer to proactively manage the global safety aspects for a specific product, or group of products.
• Provide safety expertise to the international project team for assigned products including the production and maintenance of Risk Management Plans and contribute to safety analyses in regulatory submissions, e.g. MAAs.
• Lead the production and amendment of safety information, including CCDS sections and associated supporting documentation, for specified products.
• Lead the safety related aspects of the design and conduct of clinical studies, including involvement in protocol and Investigators' Brochure development, monitoring of safety signals and review of clinical study reports.
• Provide senior medical representation for the company's Safety, regionally and globally.
• Establish and maintain a high level of familiarity with the international and European pharmacovigilance regulations and guidance relating to drug safety and pharmacovigilance and act as a point of reference for others.
• The Head of Safety Evaluation may act as Deputy EU QPPV

Skills and Requirements:

• Medically qualified (MD, MB BS or equivalent) and demonstrated experience in post-registration clinical medicine.
• Extensive experience within pharmacovigilance and/or clinical development and proven experience and demonstrated competence in safety surveillance and risk management
• Previous line management experience is desirable
• Able to work independently, establishing work priorities and direction
• Demonstrates excellent scientific/ clinical and analytical knowledge and skills, with ability to assess complex data, understand the medical implication.
• Excellent communications skills, including ability to present complex information clearly
• Well-developed influencing skills with ability to lead and influence in a cross-functional/ matrix environment without direct authority
• Team player and able to provide mentoring and support to less experienced team members
• Able to form strong cross-functional relationships.

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 Kevin Hansberry on +44 207 4400 636 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.