(Apply Now) Pharmacovigilance Senior Specialist

3 weeks ago

Dublin Pike, Ireland Xeolas Full time

Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 80+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets.
We are now seeking an experienced Pharmacovigilance Senior Specialist to join our expanding team in Ireland. This role is ideal for an experienced PV professional looking to take on strategic responsibilities and contribute to the continued excellence of pharmacovigilance operations.
Role Summary As a Pharmacovigilance Senior Specialist, you will be responsible for overseeing and executing a wide range of pharmacovigilance activities, ensuring compliance with global regulatory standards. You will provide expert guidance on safety case management, regulatory documentation, and inspection readiness, while also mentoring team members and supporting client relationships.
Key Responsibilities Safety Case Management:
Oversee the processing and reporting of Individual Case Safety Reports (ICSRs).
Ensure accurate and timely maintenance of safety databases.
Process PV events, and product quality complaints in line with the organisation's operating procedures
Perform mailbox triage and management, case processing, reconciliation, query management and other tasks to ensure compliance with pharmacovigilance procedures.
Regulatory Documentation:
Draft, review, and finalize Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs).
Ensure documentation is completed in accordance with regulatory timelines and client expectations.
Compliance & Quality Systems:
Ensure adherence to internal quality systems and global pharmacovigilance regulations.
Lead and support audits and inspections conducted by regulatory authorities.
Develop and implement corrective and preventive actions (CAPAs) as needed.
Act as a key point of contact for clients, providing expert PV advice and support.
Mentor and guide junior PV staff, fostering professional development and knowledge sharing.
Stay current with evolving regulatory requirements and industry best practices.
Contribute to the enhancement of PV processes, SOPs, and systems.
Qualifications & Experience Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field (advanced degree preferred).
Minimum of 5 years' experience in pharmacovigilance within the pharmaceutical or regulatory services industry.
Strong understanding of EU and global PV regulations and guidelines.
Proven experience in case processing, safety database management, and regulatory submissions.
Demonstrated ability to manage audits and inspections effectively.
Excellent communication, organizational, and problem-solving skills.
Ability to work independently and collaboratively in a fast-paced environment.
Apply for this Job Please send a cover letter and your cv to

#J-18808-Ljbffr

  • Pharmacovigilance Senior Specialist

    3 days ago

    Dublin, Ireland Xeolas Full time

    Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 80+ employees. We develop and manufacture innovative patient friendly pharmaceutical products for international markets. We are now seeking an experienced Pharmacovigilance Senior Specialist to join our expanding team in Ireland. This role is ideal for an experienced...

  • Qualified Person for Pharmacovigilance

    24 hours ago

    Dublin, Ireland Cpl Full time

    Qualified Person for Pharmacovigilance (QPPV)On behalf of our client, we are currently recruiting for a Qualified Person for Pharmacovigilance (QPPV). This person can be predominantly remote with occasional travel to Irish office.Purpose of JobAct as company nominated EEA QPPV to meet all EEA QPPV responsibilities (as defined in current EU Directive /83/EC,...

  • Qualified Person for Pharmacovigilance

    21 hours ago

    Dublin, Ireland CPL Full time

    Qualified Person for Pharmacovigilance (QPPV) On behalf of our client, we are currently recruiting for a Qualified Person for Pharmacovigilance (QPPV). This person can be predominantly remote with occasional travel to Irish office. Purpose of Job Act as company nominated EEA QPPV to meet all EEA QPPV responsibilities (as defined in current EU Directive...

  • ▷ [Apply Now] Senior Software Engineer

    2 weeks ago

    Dublin Pike, Ireland Wealth.com Full time

    Join to apply for the Senior Software Engineer role at Wealth.com . The range is provided below and your actual pay will be based on your skills and experience. Talk with your recruiter to learn more. Base pay range Compensation Range: €93K - €102K About Wealth.com Wealth.com is the industry’s leading estate planning platform, empowering...

  • CLM Senior Specialist

    3 weeks ago

    Dublin, Ireland Citco Group of Companies Full time

    CLM Senior Specialist Dublin - Ireland About Citco Citco is a global leader in fund services, corporate governance and related asset services with staff across 50 office Locations worldwide. With more than $1.8 trillion in assets under administration, we deliver end-to-end solutions and exceptional service to meet our clients’ needs. For more...

  • [Apply Now] Compensation

    2 weeks ago

    Dublin Pike, Ireland Darwin Hawkins Full time

    Compensation & Benefits Specialist – 6 Month FTC Job Title: Compensation & Benefits Specialist – 6 Month FTC Sector: Insurance Location: Dublin City Centre (Hybrid – 2 days on‑site) Salary: €70,000 – €75,000 plus completion bonus and benefits Our client is a well‑established and respected player in the insurance sector. Based in...

  • Payroll Specialist

    7 days ago

    Dublin, Ireland Hays Specialist Recruitment Full time

    Your new company This well-established group operates across investment property and builders' merchandising, with a strong footprint in Dublin and beyond. Since acquiring a major builders provider in 2021, the business has expanded to 10 branches and now ranks second in its sector nationally. With continued growth and a commitment to operational excellence,...

  • Locum Psychiatrist – CAMHS

    3 weeks ago

    Dublin Pike, Ireland TTM Healthcare Limited Full time

    Overview TTM Healthcare are currently recruiting a Locum Psychiatrist - CAMHS for a role in Dublin. If this opportunity is of interest to you, whatsapp Roisin McSweeney on 0860840063 / click APPLY NOW or / email roisin.mcsweeney@ttmhealthcare.com today to arrange an interview. TTM has been awarded Tier 1 supplier status by the HSE for the provision of...

  • Commercial Manager

    3 weeks ago

    Dublin Pike, Ireland Headcount Solutions Full time

    Human Resources Administrator @Headcount Solutions Location: Ireland (with site travel as required occasionally to Europe) Reports To: Managing Director About Cross Technical Services Cross Technical Services is a specialist Refrigeration & HVAC contractor delivering high-quality mechanical projects across Ireland and Europe, with project values ranging...

  • (Apply Now) Application Management Specialist

    3 weeks ago

    Dublin, Ireland ResMed Inc Full time

    Application Management Specialist page is loaded## Application Management Specialistlocations: Dublin, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: JR/_045331Global Technology Solutions (GTS) at ResMed is a division dedicated to creating innovative, scalable, and secure platforms and services for patients, providers, and...