Medical Director

1 day ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time
Job Description

Cpl Healthcare is seeking a highly skilled Medical Director, Global Drug Safety and Pharmacovigilance to join our team.


Duties and Responsibilities

The ideal candidate will be responsible for implementing and coordinating safety surveillance procedures for products. This includes:

  1. Developing and leading safety activities and benefit-risk strategies throughout the life-cycle for assigned products in post-marketing, clinical development or both.
  2. Oversight, preparation, contribution, and/or review of 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.
  4. Develop strategy for signal evaluation.
  5. Prepare and Review Signal Evaluation Reports (SERs) and ad hoc regulatory responses.
  6. Presentation of safety signals to development team and Global Safety Committee.
  7. Responsible for the medical review of all sources of safety information including ICSRs, product complaints, and requested medical information queries for assigned products.
  8. Contribute to safety labelling activities for products and ensure safety labelling adequately reflects emerging post marketing safety profile.
  9. Provide medical support to the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
  10. Provide support to clinical development teams regarding emerging benefit-risk profile, appropriate safety monitoring during clinical trials and safety strategy for drugs in development.
  11. Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned projects.
  12. 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.
  13. Participate in company initiatives as a drug safety representative.
  14. May oversee activities delegated to other personnel.
  15. Mentor junior drug safety personnel, including drug safety scientists.
  16. Participate as required in internal audits and Health Authority inspections.
  17. Maintain current knowledge and understanding of regulations, ICH guidelines and industry practices in relation to pharmacovigilance.
  18. Attend product team meetings as needed, safety team meetings, company safety governance meetings, and regulatory interactions.

  • Medical Director

    4 hours ago


    Dublin, Dublin City, Ireland WEP Clinical Full time

    Do you want to be a part of a team that gives hope to patients with rare and life-threatening diseases? Do you thrive in an innovative, growth-oriented environment? At WEP Clinical, we are looking for an experienced Medical Monitor interested in joining us in an exciting phase of high growth and helping us shape the future of clinical research.Role...

  • Medical Director Position

    36 minutes ago


    Dublin, Dublin City, Ireland TTM Healthcare Solutions Full time

    Job Title: Medical Director Position - General SurgeryTTM Healthcare Solutions is seeking an experienced and highly skilled Medical Director to lead our General Surgery department.This is a fantastic opportunity for a talented and dedicated professional to take on a senior leadership role and drive excellence in our organization.The ideal candidate will have...


  • Dublin, Dublin City, Ireland Alliance Medical Ltd. Full time

    Job Description:Alliance Medical Ltd. is currently recruiting for a Business Development Specialist to join our team in the Dublin region and surrounding areas of Kildare and Wexford.The successful candidate will be responsible for building, supporting, and maintaining relationships with our diverse customer base, as well as identifying and developing new...


  • Dublin, Dublin City, Ireland OASIS Group Full time

    Job DescriptionOASIS Group is seeking a highly skilled and dedicated Medical Director Assistant to join our team at Wexford General Hospital. As a key member of our clinical team, you will be responsible for providing exceptional medical care to patients and contributing to the development of our hospital's services.Key ResponsibilitiesParticipate in...


  • Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Job OverviewClinical Development Medical Directors at Novartis are responsible for the scientific and clinical strategy of assigned clinical trials. They work closely with global line functions, trial directors, and medical associates to ensure successful program execution. Key responsibilities include providing clinical leadership, driving trial execution,...


  • Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Clinical Development Medical Director - RheumatologyJob ID REQ-10040285Feb 26, 2025IrelandSummaryAs our Clinical Development Medical Director in our Immunology Development Unit, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.The Clinical Development Medical...


  • Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Clinical Development Medical Director - RheumatologyJob ID REQ Feb 26, 2025IrelandSummaryAs our Clinical Development Medical Director in our Immunology Development Unit, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.The Clinical Development Medical Director...

  • Medical Director

    5 hours ago


    Dublin, Dublin City, Ireland Beaumont Private Clinic Full time

    About the RoleWe are seeking a skilled and experienced Medical Director to lead the daily operations of our private clinic. The ideal candidate will have a strong background in healthcare administration, with experience in managing small to medium-sized projects.The successful candidate will work closely with our Management Executive Group to develop and...

  • Medical Director

    33 minutes ago


    Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Key Responsibilities:Provide clinical leadership and medical strategic input for deliverables in the assigned project/program, including sections of individual protocols, data review, program specific standards, clinical components of regulatory documents, and publications.Drive execution of the section of the program in partnership with global line...


  • Dublin, Dublin City, Ireland Icon Full time

    About ICONICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to fostering an inclusive environment that drives innovation and excellence. Our mission is to shape the future of clinical development, and we invite you to join us on this journey.Job DescriptionThe Medical Director of a High Complexity Clinical...


  • Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Associate Clinical Development Medical DirectorJob ID REQ-10030826Feb 04, 2025IrelandSummaryThe Associate/Clinical Development Medical Director (CDMD) is responsible for leading the planning and management of the assigned RLI clinical program(s) to support the RTL trials from an end-to-end clinical development perspective. As CDMD, you will have oversight of...

  • Medical Director

    2 days ago


    Dublin, Dublin City, Ireland Icon Full time

    As a Medical Director at ICON Clinical Laboratories, you will be responsible for the overall oversight, management, and direction of medical and scientific aspects of the laboratory operations. This role ensures compliance with all regulatory and accreditation requirements, guides clinical decision-making, and ensures that the laboratory's testing services...


  • Dublin, Dublin City, Ireland Oasis Group Full time

    Transforming Child HealthcareAt Children's Health Ireland, we are committed to transforming child healthcare through innovation, excellence, and compassion. As a Medical Director for Paediatrics, you will play a critical role in leading our efforts to deliver world-class care to children and families.About Our MissionOur mission is to provide child-centred,...


  • Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Job DescriptionWe are seeking an experienced Clinical Development Medical Director to lead our rheumatology program. In this role, you will be responsible for developing and executing clinical strategies, leading cross-functional teams, and overseeing medical and scientific review of trial data. The ideal candidate will have advanced knowledge and training...


  • Dublin, Dublin City, Ireland Ie02 (Fcrs = Ie002) Novartis Ireland Ltd Full time

    Summary As our Clinical Development Medical Director in our Immunology Development Unit you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.About the Role The Clinical Development Medical Director (CDMD) for Dermatology is the clinical leader of defined program...


  • Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.To do this, we are optimizing and strengthening our processes and ways of working.We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.We...

  • Medical PA

    2 weeks ago


    Dublin, Dublin City, Ireland Lex Consultancy Full time

    A leading healthcare organisation is seeking an experienced  Medical PA  to provide high-level support to the Clinical Director and Academic Lead. This role requires exceptional  organisational, communication, and multitasking skills , along with a strong ability to manage a busy office in a fast-paced medical environment. Location:  South County...


  • Dublin, Dublin City, Ireland Jordan martorell s.l. Full time

    Job DescriptionTHE POSITION:Medical Information is a critically important customer-facing function that supports the safe and effective use of pharmaceutical company products by providing timely, scientifically balanced, evidence-based, non-promotional information in response to unsolicited requests from healthcare professionals, patients, caregivers, and...


  • Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.We...


  • Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

    Our Medical Affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional...