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AX-7291 Risk Benefits Manager

AXESS Ltd Published: 9th September 2019
Location
Berkshire, United Kingdom
Job Type

Description

Ref: AX-7291

 

JOB SUMMARY

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.

 

BACKGROUND

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

 

PRIMARY DUTIES

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.

 

BENEFITS:

Car Allowance, Bonus, Pension, Private Medical  & Life Assurance

 

TO APPLY:

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.

 

KEYWORDS:

PV Risk Manager / PV Risk Benefits Manager / PV Risk Assessment Manager / Senior PV Manager / PV Manager / PV Risk Manager / Bucks / Berks / M25 PV jobs / PV Risk Manager / Reading / maidenhead / Slough / Marlow / Hurley / Henley / Deputy QPPV / Local Affiliate / UK Affiliate / Global Projects / Risk Benefit Analysis / Risk Benefit / Safety Risk Management / RMPs / UK / Berkshire

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market.

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