- Experience Level
Salary: Up to 60,000 + Benefits
CPL Life Sciences are looking for a Pharmacovigilance Manager to join a small but growing biopharmaceuitcal company based in Surrey. This exciting business focus on the development and commercialisation of drugs to treat metabolic and genetic diseases.
As a PV Manager within this organisation, you will provide hands-on day-to-day leadership of a small team covering all pharmacovigilance (PV) functions. You will be work closely with the EU QPPV and medical team to monitor the ongoing benefit-risk balance of a novel drug used in orphan indications and clinical trial use.
- Work closely with the Head of Quality and Drug Safety and the EU QPPV to review and
implement PV processes and procedures where required.
- Develop SOPs
- Oversee signal detection and risk management
- PSMF Management
- Review and approve aggregate reports (PSURs) and (PADERs)
- CAPA management
- Oversee case management and case handling, including providing back-up support for
case handling staff where needed
- Serve as the pharmacovigilance subject matter expert for internal audits and regulatory
- Previous experience of working in a senior/managerial level role within
- Demonstrable experience of manging or mentoring staff
- Full understanding of the role of PV within clinical and post-marketed stages
- Strong technical PV knowledge including aggregate reports, signal detection and risk
- Experience leading audits and inspections
- A willingness to be hands on when needed, but the ability to provide higher level
- Life Science Degree
This is a permanent role, based in Surrey, offering 2-3 days' home-working although currently fully remote. The successful applicant will be rewarded with a competitive salary and benefits as well as playing a pivotal role in the growth of the business.
If this role is of interest, please send your CV to George.Danchie@cpl.com or call 0118 959 4990 for more information.
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