Associate Director - Medical Review

Regulatory Affairs/Clinical Affairs Nazareth, Belgium


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

Position: Associate Director – Medical Review

Location: Dublin, Ireland or Nazareth, Belgium

 

Perrigo is actively looking for an Associate Director – Medical Review to join our Global Patient Safety department reporting into the Sr. Director CSCI Global Patient Safety. This position can be based at either our Dublin, Ireland or Nazareth, Belgium locations.  This position will act as Internal & External Safety and Medical Expert: ensure the continuous management of the safety profile for our products, allowing efficient risk management, proactive Signal Management, and the contribution to ongoing evaluation of the benefit-risk profile.

 

Responsibilities:

Signal Management/ Benefit-Risk Assessment

  • You will have a full oversight on the signal management process, and you will have a key role on the continuous improvement of that process
  • Leading & Coordinating signal management activity
  • Lead the preparation and the governance of the company Risk Management Steering Group
  • Coordinating the preparation meetings & acts as the spokesperson through the agenda of Risk Management Steering Group.
  • Responsible for the internal Safety committee
  • You develop risk management strategies and plans and monitor effectiveness.
  • You co-lead benefit-risk assessment with other relevant Safety functions (EU QPPV, BRE colleagues)
  • Review and approval of the cumulative review documents & Company Core Safety Information
  • Medical Review & Approval of Safety reports such as RMP, PSUR/PBRER and signals
  • You maintain knowledge of product, product environment and recent literature.
  • You ensure appropriate KPIs are implemented where appropriate

Medical Expertise and support

  • Provide continuous medical support and medical advice for the EU QPPV
  • Provide a medical Risk Assessment report in a timely manner to support escalated events decision making
  • Work in close collaboration with Innovation and R&D on new products developments (NPD)
  • When needed you act as Medical advisor to support Regulatory affairs with different health authorities’ requests
  • Clinical support for medical enquiries from consumers, HCP, CA or other internal departments.
  • Support for regulatory inspections and actively participate to their preparation
  • Write medical responses or contributions for the health authorities related enquiries.
  • Work with a cross functional teams when needed to realize deadlines for health authority requests and submissions.
  • Creating medical presentations when needed to support the knowledge about our portfolio

Your profile:

  • MD/PhD/Pharmacist required
  • You have at least 4 years of significant and successful experience in Drug safety with 2 to 4 years in Risk management Job and/or safety documents writing and signal detection
  • Highly analytical, process minded and detail oriented.
  • Be able to work in a matrix environment whilst remaining organized at all times.
  • You have a hands on-mentality and a proactive attitude.
  • You are a true team player
  • You are fluent in English and have excellent communication skills. Knowledge of other European languages is an asset.