Risk Management Consultant (Pharmaceutical)
Risk Management Consultant for the Pharmacovigilance and Epidemiology (PVE) team.
18 month contract - based in Cambridge - paying c45.00 per hour.
The PVE department's key goal is to protect patients receiving our client's investigational and marketed products, ensuring compliance with global safety reporting and performing continuous risk/benefit evaluation throughout the life cycle of a product.
Specifically, the successful candidate will work in the HIV therapeutic area team within Risk Management.
Skills and Experience:
- Previous experience working in pharmacovigilance, particularly risk management, is essential for this role.
- Previous experience of preparing regulatory documentation would be useful as this is a key element of the role and consequently the candidate should have strong communication skills.
- Excellent attention to detail, teamwork and initiative, meticulous attention to project deadlines and maintaining confidentiality at all times
- Degree qualified (e.g. BSc, BA, MSc or PhD) or a professional qualification in a health science field or a relevant scientific/technical discipline
Role and Responsibilities
You will be conducting global risk management and signal detection/evaluation activities across:
- Authorship of aggregate safety reports (e.g. PSURs/PBRERs, DSURs)
- Authorship of risk management plans
- Signal detection and authorship of signal work-up documents in collaboration with a safety physician
- Review of global literature for identification of potential safety concerns
- Ownership of the responses to regulatory agency safety enquiries
To learn more about our client and their exciting plans and how you can join them for an 18 month contract assignment working as a PVE focused Risk Management Consultant based in Cambridge; please call and speak with Iain Brassell here at ISR in our London offices or please email me a copy your very latest and/or online profile for an immediate call back in the strictest confidence.