Associate Director - Global Drug Safety Physician

Regulatory Affairs/Clinical Affairs Dublin, DB


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 – Global Drug Safety Physician

Location: Flexible. Dublin, Ireland - Belgium - London, England 

 

Perrigo is actively looking for an Associate Director –Global Drug Safety Physician 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 of all Perrigo products. From time to time this individual may also represent Perrigo’s safety voice at external or regulatory engagements. It will be the responsibility of this role to strategically lead the Safety response for the Perrigo portfolio. This includes signal detection, benefit/risk assessment and risk management activities [including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)], as well as other activities related to managing the safety profile of Perrigo products.

 

Scope: Global Patient Safety (International & America)

Signal Management/ Benefit-Risk Assessment:

  • Provides oversight of the signal management process and has a key role in the continuous improvement of that process
  • Leading & Coordinating signal management activity
  • Lead the governance of the company Risk Management Steering Group
  • Oversight on the internal Safety committee
  • Develops product risk management strategies and plans and monitors effectiveness.
  • Leads the benefit-risk assessment with other relevant Safety functions (EU QPPV, BRE colleagues)
  • Review and approval of the aggregate review safety documents & Company Core Safety Information
  • Medical Review of ICSRs and approval of safety reports such as RMP, PSUR/PBRER and signals
  • Maintains knowledge of product, product environment, regulatory environment and recent literature.
  • Ensures appropriate KPIs are implemented where appropriate

Medical Expertise and support:

  • Provide continuous medical support and medical advice for the EU QPPV and other safety department colleagues
  • Provide a medical Risk Assessment report in a timely manner to support escalated events decision making in collaboration with the quality department
  • Contributing to the scientific analysis and review of various sources of safety data using the knowledge of the regulations.
  • Managing and overseeing the identification of risks and prioritizes the risks and mitigation actions that provide value for patients.
  • Managing the synthesis and interpretation of safety and epidemiological data, identifying insights that can be used to differentiate products and support decision making.
  • Work in close collaboration with Innovation and R&D on new products developments (NPD)
  • When needed acts as Medical advisor to support Regulatory affairs with different health authorities’ requests
  • Clinical support for medical enquiries from consumers, patients, HCP, CA or other internal departments.
  • Support for regulatory inspections and actively participate in 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 disease state medical presentations when needed to support the knowledge about our portfolio

 Your profile:

  • MD is required
  • You have at least 3-5 years of significant and successful experience in Drug safety with 2 to 4 years in risk management and/or safety documents writing and signal detection
  • Highly analytical, process minded and detail oriented.
  • Be able to work in a matrix environment
  • Hands on-mentality and a proactive attitude.
  • A true team player
  • Fluent in English and have excellent communication skills. Knowledge of other European languages is an asset.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.