A leading pharmaceutical client is searching for a Pharmacovigilance Operations Director to join their team in the South East of the UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe. The Director role will entail, leadership and management of the EMEA Pharmacovigilance Operations team responsible for pharmacovigilance activities within Europe, Middle East, Africa and Australia region including: regional case processing and regulatory submissions, alliance management, compliance and quality assurance activities, training and oversight of affiliate network of safety offices.
- Lead the EMEA Pharmacovigilance Operations team, its ongoing projects, processes and staff
- Lead the implementation of procedures at regional level which ensure the quality, regulatory compliance and efficiency of pharmacovigilance activities delivered under the EMEA office
- Provide oversight and support to ensure maintenance and implementation of appropriate PV agreements with Business Partners/ distributors
- Build and maintain close working relationships with PV peers and other EMEA functions (e.g. Regulatory and Medical Affairs) and affiliate safety groups to ensure the development and maintenance of effective collaborations
- Lead the activities to maintain and further develop the processes and systems to ensure the PV requirements for the collection and reporting of safety information from organised data collection (non-interventional programmes) are met in the EMEA region
- Maintain knowledge of EU and other regional PV legislation and, as appropriate, lead and support impact analysis on Health Authority proposals for changes in pharmacovigilance regulations and guidelines to provide guidance on implementation
- Supporting, mentoring and line management of EMEA based PV team of approximately 10 staff
- Close interactions with other members of the global drug safety community, including corporate site in Japan, Global Safety Assessment Office in US and safety personnel
- Close interactions with other departments, including Clinical, Regulatory, Business Development and Medical Affairs.
- Participates in and may lead cross-functional teams within and external to Drug Safety
- External interactions with licensing partners, regulatory agencies and relevant industry groups
Skills and Requirements:
- A life science, pharmacy or nursing qualification and proven success in a senior pharmacovigilance role
- Extensive experience (> 8 years) within pharmacovigilance and a consistent record of strong contribution, in addition to success in tackling new challenges and responsibilities
- In depth knowledge and understanding of safety regulations for both marketed and investigational products
- Experience in planning, and managing multiple projects in a matrix or cross-functional environment
- Previous line management experience is desirable
- Experience of working across countries and cultures will be an advantage
- Excellent communication 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
- Demonstrated ability to address and resolve complex problems and to build consensus around solutions
- Team player and able to provide mentoring and coaching to less experienced team members
- Able to form strong cross-functional relationships.
- Proactive with good attention to detail
- Willingness to travel when required
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 +44 203 7520 318 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.