AX-7291 Risk Benefits Manager
Opportunity for a PV Risk Manager to join a Blue-chip Pharma in a strategic role based to the West of London, providing an effective risk management plan for the organisation. Office based role, some flexibility.
Blue-chip Pharma Company
Impressive pipeline / established products
Development opportunity – company policy to develop all employees
Excellent working environment / Modern Offices / On-site facilities
Flexible benefits including home working
Responsibilities of the PV Risk Benefits Manager is awareness of any local Regulatory Agency safety request and liaising with Regulatory Affairs to enable timely notification to global RA and PV teams and appropriate response to requestor. Input into safety-related product enquiries/issues received from external stakeholders/vendors, working with Medical Affairs, Regulatory Affairs and PPS as required.
To Monitor incoming safety information and communicates changes or concerns to PPS Product Safety Team (PST) Lead and the EU QPPV (for products marketed in the EEA) and/or local QPPV as applicable for evaluation.
You’ll ensure the scheduling of locally required Periodic Safety reports (clinical and post-marketing), and submissions, prepare local periodic safety reports and ensures alignment and documentation of responsibilities.
You’ll be a core team member of the Affiliate Risk Management Team (ARMT); contributing to ARMT strategy for effective risk management plan implementation; management of risk minimisation materials – review of materials from a local perspective, local HA approval, oversight and tracking of distribution and input of distribution/tracking data into PRISM. You will also serve as main pharmacovigilance contact for non-ODC programs and activities including, but not limited to, RWE studies, Investigator Initiated Studies, PMOS, PASS, Registries etc.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Degree in life sciences (medicine, veterinary medicine, pharmacy, (human) biology etc.)
Knowledge of relevant UK and EU regulatory requirements
Professional experience in pharmacovigilance, preferably in pharmaceutical companies
High degree of familiarity with national and European legislation (AMG, MPG, Good Pharmacovigilance Practice etc.)
Experience in conducting training sessions
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
Car Allowance, Bonus, Pension, Private Medical & Life Assurance
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300 quoting reference 7291.
To apply, please click the APPLY ONLINE button.
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