Senior Safety Scientist

1 week ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

Medical Director, Global Drug Safety and Pharmacovigilance (GDSP)

Reporting to the SVP of GDSP, the Medical Director, GDSP will work in tandem with the Senior Medical Director, GDSP to implement and coordinate safety surveillance procedures for products.

Duties and responsibilities will include:

  1. Develop & lead safety activities and benefit-risk strategies throughout the life-cycle for assigned products in post-marketing, clinical development or both.
  2. Oversee, prepare, contribute, and/or review aggregate safety review documents (e.g., DSUR, PBRER), PSMF and selected clinical documents including regulatory filings and risk management plans.
  3. Lead evaluation and management of signals emerging from any data source. Develop strategy for signal evaluation. Prepare and Review Signal Evaluation Reports (SERs) and ad hoc regulatory responses.
  4. Presentation of safety signals to development team and Global Safety Committee.
  5. Responsible for the medical review of all sources of safety information including ICSRs, product complaints, and requested medical information queries for assigned products.
  6. Contribute to safety labelling activities for products and ensure safety labelling adequately reflects emerging post marketing safety profile.
  7. Provide medical support to the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
  8. Provide support to clinical development teams regarding emerging benefit-risk profile, appropriate safety monitoring during clinical trials and safety strategy for drugs in development.
  9. Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
  10. Act as safety lead on assigned projects with Business Partners, Vendors, Clinical Development Teams and Post Marketing Project Teams and in interactions with Medical Monitors and other personnel.
  11. Participate in company initiatives as a drug safety representative.
  12. May oversee activities delegated to other personnel.
  13. Mentor junior drug safety personnel, including drug safety scientists.
  14. Participate as required in internal audits and Health Authority inspections.
  15. Maintain current knowledge and understanding of regulations, ICH guidelines and industry practices in relation to pharmacovigilance.
  16. Attend product team meetings as needed, safety team meetings, company safety governance meetings, and regulatory interactions. Some travel may be required for safety meetings with partners, vendors, and regulatory authorities, and for attendance at conferences.

EU dQPPV specific responsibilities:

  1. Act as pharmacovigilance's single point of contact for the EU Competent Authorities, the UK authority, and European Medicines Agency (EMA) on a 24 hour/7 day a week basis when acting as the QPPV.
  2. Assists the EU QPPV in oversight and management of the PV System that covers all products with a marketing authorization in the European Union (EU) and the UK.
  3. Assists the EU QPPV in ensuring an accurate benefit-risk assessment of all products marketed in the EU is reflected in correct and complete data submitted to European authorities including the EMA, PRAC and national CA.
  4. Assists in the pharmacovigilance aspects of all product recalls or DHCP communications in the EU and UK.

The successful candidate will have:

  1. MD or equivalent, with a minimum of 3 years of pharmacovigilance experience required. If candidate does not have pharmacovigilance experience, must have at least 4 years of pharmaceutical experience in scientific area such as clinical development, regulatory or medical affairs.
  2. Reside in the EU and meet all requirements for registration as an EU QPPV.
  3. Expert knowledge of EMA safety regulation, GVP, ICH Guidelines, and other applicable regulatory requirements and guidance documents including FDA safety regulations; expertise in global pharmacovigilance regulations.
  4. Expertise in clinical safety assessments, safety signal detection and risk management, Ability to evaluate, interpret and synthesize scientific data (analytical thinking).
  5. Highly self-motivated with a demonstrable passion for pharmacovigilance and strong interpersonal skills.
  6. Ability to present and critically discuss clinical data in both internal and external discussions including interactions with regulatory authorities.
  7. Ability to work with cross function safety teams and global safety teams (internal and involving business partners).
  8. Excellent written and oral communication in English.
  9. Ability to work with others at all levels and from a wide range of backgrounds in the company (incl. internal and external), able to lead through influence.

For more information please contact Clodagh D'Arcy on 01 9476356 or email details to Clodagh.darcy@cpl.ie

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