Benefits Risk Manager (New strategic position & Deputy QP)

Created by: AbbVie
Added: 09.10.2019

Advert description

Benefits Risk Manager (New Strategic Position & Deputy QP)

Based in our Maidenhead offices with up to 5% travel

Reporting to the Head of Pharmacovigilance UK
Competitive salary, car allowance, bonus and comprehensive benefits package

The Company

AbbVie is an ambitious health business where people and quality of life come first. The experience of illness is personal, so we care about the things that matter to patients. As market leader, we team with partners to co-design health solutions around our innovative medicines for complex diseases, which improve standards of care. Helping people to be fit for work and family life is how we make a remarkable impact to the lives of men, women and children.

The Role

This newly created role in the UK PV Team will have a balance of responsibilities. The role will have a strategic focus and will aim to bring a scientific insight into the UK PV team while working and building relationships with global and 3rd parties. This person will also be the Deputy QP after Brexit and the face for AbbVie liaising with the MHRA.

Highlighted Responsibilities
  • Awareness of any local Regulatory Agency safety request and liaison with Regulatory Affairs to enable timely notification to global RA and PV teams and appropriate response to requestor.
  • Awareness of and input into safety-related product enquiries/issues received from external stakeholders/vendors, working with Medical Affairs, Regulatory Affairs and PPS as required.
  • Monitors 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.
  • Ensures the scheduling of locally required Periodic Safety reports (clinical and post-marketing), and submission to Regulatory Authority, Ethics Committees and Investigators as required in accordance with the due dates.
  • Prepares local periodic safety reports (if required) and ensures alignment and documentation of responsibilities between PPS, Regulatory Affairs and Affiliate PV
  • RMP Management: core team member of the Affiliate Risk Management Team (ARMT); contributes 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.

Experience & Desired Behaviors
  • Degree in life sciences or relevant transferable experience.
  • Previous experience in pharmacovigilance, preferably in pharmaceutical company.
  • Excellent knowledge of UK, EU and Global pharmacovigilance legislation is a must.
  • Hunger for a strategic role with matrix working.
Additional Information
  • Travel: Yes, 5 % of the Time
  • Job Type: Experienced
  • Schedule: Full-time

Specific details

Type of Contract Full time
Preferred Education Bachelor's, Master's, Other
Level of Experience 2-5 years

Location

United Kingdom, Europe
Maidenhead