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 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.

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