Director of Pharmacovigilance Operations

7 days ago


Dublin, Dublin City, Ireland Regeneron Ireland Dac Full time

Job Description

This role serves as the first point of contact for all safety-related issues for assigned compounds. The Global Patient Safety Lead leads the safety strategy, ensures optimal support, and collaborates with stakeholders to deliver the safety strategy.

Main Responsibilities

  1. Act as a resource for medical review for complex ICSRs and other data sources of assigned compounds
  2. Participate in the development and maintenance of relevant SOPs, working practices, and guides
  3. Cultivate cross-functional relationships and mentor junior safety scientists

Required Skills and Qualifications

  • Able to apply and provide critical analysis of relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities
  • Subject matter expert internal and external to GPS for assigned compounds with relevant clinical industry experience in the therapeutic area of interest


  • Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

    Regeneron Ireland DAC is an equal opportunities employerWe are committed to creating a diverse and inclusive workplace where everyone feels valued and supported. As a Director of Pharmacovigilance, you will play a key role in shaping our safety organization and contributing to the development of new medicines.This role offers:Opportunities for professional...


  • Dublin, Dublin City, Ireland CPL Full time

    About the JobCPL seeks a seasoned pharmacovigilance professional to spearhead our safety initiatives across multiple products. As a Pharmacovigilance Director, you will oversee the implementation of safety protocols, develop risk management strategies, and coordinate the preparation of aggregate safety reports.Key AccountabilitiesDevelop and execute...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    About the JobCpl Healthcare is seeking a highly skilled Medical Director to lead our global drug safety organization. The successful candidate will have expertise in pharmacovigilance, clinical safety assessments, and risk management.Key Responsibilities:Develop and Implement Safety StrategiesLead Aggregate Safety Reviews and Risk Management PlansEvaluate...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Job OverviewCpl Healthcare is seeking a highly skilled Medical Director to lead our pharmacovigilance team. This is an exciting opportunity for a medical professional with expertise in safety surveillance and risk management to join our global drug safety organization.Key Responsibilities:Develop and Implement Safety StrategiesLead Aggregate Safety Reviews...


  • Dublin, Dublin City, Ireland PuroClean Certified Restoration Specialist of Auburn Full time

    Pharmacovigilance Specialist On behalf of our client, a Global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Specialist based in Dublin. Your role will be to support the Global Pharmacovigilance Team with but not limited to the Safety Data Exchange Agreements management, Quality Management System related activities, service...


  • Dublin, Dublin City, Ireland PuroClean Certified Restoration Specialist of Auburn Full time

    Pharmacovigilance SpecialistOn behalf of our client, a Global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Specialist based in Dublin.Your role will be to support the Global Pharmacovigilance Team with but not limited to the Safety Data Exchange Agreements management, Quality Management System related activities, service...


  • Dublin, Dublin City, Ireland Recruitment By Aphex Group Full time

    Job Summary:We are seeking a highly skilled and experienced Pharmacovigilance Leadership Director to join our team. As a leader in your field, you will have a proven track record of success in developing and executing strategic initiatives, as well as building and maintaining effective relationships with business partners.Key Responsibilities:Lead the...


  • Dublin, Dublin City, Ireland Zymeworks Full time

    Key Responsibilities Provide dynamic leadership, strategic direction, and governance of patient safety and pharmacovigilance activities across our portfolio. Model and encourage adherence to the Zymeworks values and mission. Coach and mentor staff, including direct reports, ensuring appropriate levels of accountability. Support department...


  • Dublin, Dublin City, Ireland Recruitment by Aphex Group Full time

    Job Summary: As a key member of our team, the Global Pharmacovigilance Senior Manager will be responsible for leading the development and execution of international initiatives for lifecycle management of external relationships.The successful candidate will have a proven track record in pharmacovigilance and experience in developing and implementing...


  • Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

    About Regeneron Ireland DACWe are a global biotechnology company committed to discovering and developing innovative treatments for serious diseases. Our goal is to improve human life by harnessing the power of science.Job DescriptionThis role is responsible for leading the safety strategy and ensuring optimal support from within Global Patient Safety. The...


  • Dublin, Dublin City, Ireland PuroClean Certified Restoration Specialist of Auburn Full time

    **About Us**PuroClean Certified Restoration Specialist of Auburn is a leading provider of restoration services in Dublin. We are dedicated to delivering high-quality solutions that meet the needs of our clients.**Job Description**We are seeking an experienced Pharmacovigilance Specialist to join our Global Pharmacovigilance Team. As a key member of our team,...


  • Dublin, Dublin City, Ireland Recruitment By Aphex Group Full time

    About the RoleWe are seeking an experienced Senior Manager - Global Pharmacovigilance Operations to join our team at Recruitment By Aphex Group. In this role, you will be responsible for developing, implementing, and managing external relationships within the GPS organization.Key Accountabilities:Implement and provide input into all PSAM team goals and...


  • Dublin, Dublin City, Ireland Recruitment By Aphex Group Full time

    Job OverviewThe Senior Manager - Global Pharmacovigilance Operations will play a key role in developing, implementing, and managing external relationships within the GPS organization. This position will be responsible for leading cross-functional strategic initiatives that ensure external relationships are consistent with regulations and organizational...

  • Senior Manager

    4 days ago


    Dublin, Dublin City, Ireland Recruitment By Aphex Group Full time

    Job SummaryThe Senior Manager - Global Pharmacovigilance Operations will be responsible for leading cross-functional strategic initiatives that ensure external relationships are consistent with regulations and organizational needs. This position will also develop and maintain safety agreements with business partners that align with functional capabilities...


  • Dublin, Dublin City, Ireland Recruitment By Aphex Group Full time

    Key ResponsibilitiesThe Senior Manager - Global Pharmacovigilance Operations will be responsible for the following key responsibilities:Implement and provide input into all PSAM team goals and strategies.Lead the execution of cross-functional strategic initiatives that ensure external relationships are consistent with regulations and organizational...


  • Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

    Join our team at Regeneron Ireland DAC and take on the challenge of leading Pharmacovigilance (PV) Quality Management Systems.About This OpportunityThis leadership role plays a crucial part in ensuring global compliance with regulatory PV requirements and optimizing operational efficiency according to established industry standards.Collaborate with subject...


  • Dublin, Dublin City, Ireland Recruitment By Aphex Group Full time

    Job DescriptionWe are seeking a seasoned professional to lead our global pharmacovigilance team. As the Senior Manager of Global PV Operations, you will be responsible for developing and implementing strategies that govern the development, implementation, monitoring, and lifecycle management of external relationships within GPS.Key Responsibilities:Develop...


  • Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

    Job DescriptionThe Safety Sciences Director role serves as the first point of contact for all safety-related issues within a given therapeutic area. This position requires strong leadership and communication skills to work with stakeholders, ensure optimal support from within the department, and deliver a comprehensive safety strategy.This role...


  • Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

    Regeneron Ireland DAC is seeking an Associate Director to lead the Pharmacovigilance (PV) Quality Management System team.About This RoleThis critical position ensures compliance with regulatory PV requirements worldwide and operates efficiently in alignment with established industry practices.Develop and maintain the PV Quality Management System in...


  • Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

    We are seeking an Associate Director in GPS Standards & Training to maintain the Pharmacovigilance (PV) Quality Management System. This role is important for ensuring compliance with regulatory PV requirements in all relevant territories worldwide and operating efficiently and effectively in alignment with established industry practices. As an Associate...