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Safety Expert Leader

1 week ago

Dublin, Dublin City, Ireland CPL Full time

About the Role

CPL is seeking a highly skilled and experienced pharmacovigilance professional to lead our safety activities across various products. As a Safety Expert Leader, you will be responsible for implementing and coordinating safety surveillance procedures, developing benefit-risk strategies, and overseeing aggregate safety review documents.

Key Responsibilities

  • Develop and lead safety activities and benefit-risk strategies throughout the life-cycle of assigned products in post-marketing, clinical development, or both.
  • Oversee, prepare, contribute, and/or review aggregate safety review documents, including DSUR, PBRER, PSMF, and selected clinical documents.
  • 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.
  • Presentation of safety signals to development teams and Global Safety Committee.
  • Responsible for medical review of all sources of safety information, including ICSRs, product complaints, and requested medical information queries for assigned products.
  • Contribute to safety labelling activities for products and ensure safety labelling adequately reflects emerging post marketing safety profile.
  • Provide medical support to the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
  • Provide support to clinical development teams regarding emerging benefit-risk profile, appropriate safety monitoring during clinical trials, and safety strategy for drugs in development.
  • Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
  • 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.
  • Participate in company initiatives as a drug safety representative.
  • Mentor junior drug safety personnel, including drug safety scientists.
  • Participate as required in internal audits and Health Authority inspections.
  • Maintain current knowledge and understanding of regulations, ICH guidelines, and industry practices in relation to pharmacovigilance.
  • 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.

Requirements

  • 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 areas such as clinical development, regulatory, or medical affairs.
  • Reside in the EU and meet all requirements for registration as an EU QPPV.
  • 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.
  • Expertise in clinical safety assessments, safety signal detection, and risk management, ability to evaluate, interpret, and synthesize scientific data (analytical thinking).
  • Highly self-motivated with a demonstrable passion for pharmacovigilance and strong interpersonal skills.
  • Ability to present and critically discuss clinical data in both internal and external discussions, including interactions with regulatory authorities.
  • Ability to work with cross-function safety teams and global safety teams (internal and involving business partners).
  • Excellent written and oral communication in English.
  • 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.