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Job Location | St. Albans |
Education | Not Mentioned |
Salary | Salary negotiable |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent, full-time |
PV Manager & Senior PV Manager for a Leading Global Pharma, Career Progression Opportunities A global top-tier pharmaceutical company located in Hertfordshire (flexible/remote working is possible), with an excellent track record of developing products across multiple therapy areas, are now searching for a manager and senior manager in drug safety. They will be responsible for maximising the potential of the pharmaceutical business, solving complex issues safety issues that affect the business and ensuring that all the companies policies and procedures are followed, in line with external and global safety requirements.This leading multi-national pharma are extremely reputable and have a strong heritage of developing exciting products across multiple therapeutic areas; the company continue to heavily invest in their research and development. R&D projects include exciting new therapies for inflammatory bowel diseases through to treatments in complex and challenging areas such as haematology. This offers growth and future career progression opportunities, but also stability and security in the company. The company is very focused on progression and development in their staff and aim for 20% of their time to be spent on personal development. Further, additional coaching is provided and there is a real focus on accountability, authenticity, growth, collaboration, flexibility, and trust. Employees will be encouraged to think outside of the box!Your main responsibilities will include (but are not limited to):- Management of Individual Case Safety Report (ICSR) from all relevant sources- Safety oversight of studies and programs - Local PV activity classification and oversight of PV contracts- Service provider oversight- Ensuring PV Quality - Local PV activity classification and oversight of PV contracts- Oversight of AE reports being processed accurately and that all reportable cases are submitted to the MHRA- PV compliance (e.g. reviewing clinical trial documentation and publications)- Acting as a local process owner/subject matter expert (SME)- Line managing and training/mentoring PV staff - Oversight of Risk Management Plan Implementation To be successful in this application for the Pharmacovigilance Manager position you should have:- Previous dealings with most of the above- Strong pharmacovigilance background, experience and knowledge- Previous contribution to foundation/squad-based work OR have experience leading foundation work in a safety environment- Experience in supporting the learning & development of chapter members- A healthcare professional/scientific degreeTo apply for these exciting drug safety manager roles and have the opportunity to work with great people in an authentic environment, send over your CV to Joshua at Required skills
Keyskills :
CRO manager seni Quality Life Science compliance pharmaceutical Quality assurance officer pharma ICSR drug safety pharmacovigilance pv biotech associate case processing PVQA