An internationally known biotechnology company has an opening for a Pharmacovigilance Director to join their team in South West England. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.
Responsible for allocated pharmacovigilance activities of assigned product(s), including analysis of safety data, identification and investigation of safety signals and input into risk management strategies.
- Participate in signal management for assigned product(s) including aggregate review and assessment of product safety data from all available data sources
- Drive/contribute to the medical-scientific content for ad hoc product safety reports and responses to product regulatory queries in compliance with internal timeframes and timeframes dictated by regulatory authorities
- Assist with timely communication of product safety recommendations, proposals and/or actions to internal and external stakeholders
- Interact in safety matters with other functions; this includes, but is not limited to participating and contribution to product related SABR periodic review meetings, SABR product medical working team meetings ,product Safety Surveillance Team meetings and product Safety Monitoring Committee meetings
Education and Experience:
- GMC-registered medical practitioner or equivalent medical degree and accreditation.
- Minimum of four years' clinical experience after completion of pre-registration post.
- MRCP, MD, PhD or Postgraduate training in clinical epidemiology and biostatistics.
- Specialization or experience in the following medical disciplines: gastroenterology/hepatology, nephrology, neurology, cardiology, intensive care, or clinical pharmacology, infectious diseases, internal medicines.
- Formal management training/experience and demonstrated management skills.
- Minimum 5 year experience in the pharmaceutical industry or clinical care setting.
- Demonstrated experience in drug safety (minimum 3-5 years) which includes prior direct interactions with EU and ROW regulatory authorities (EU experience strongly preferred);
- Preferably has prior experience in clinical development;
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.