Exciting opportunities – LOOKING for a new challenge in YOUR career
Cancer Trials Ireland is a not-for-profit organisation that has the unique advantage of being made up of clinicians and scientists all invested in one goal – to find new and more effective ways to detect and treat cancer.
Working with us, you’ll be at the forefront of cancer research from the start of a concept right through to publication.
We are committed to the professional development of our staff. We offer exclusive training opportunities facilitated by our clinician members, our collaborative partners and our Scientific and Training meetings held 3 times per year.
We also understand the need for a healthy work-life balance and well-being. We offer our staff numerous incentives such as the bike-to-work scheme, the tax-saver leap card scheme and full kitchen facilities with the provision of snacks. We also have a generous holiday allowance and flexible working arrangements.
Senior Pharmacovigilance Associate/PV Manager – Full Time or Part Time considered
Head of Operations
- Third level degree in biomedical/life science/nursing.
- Knowledge of Irish and European pharmacovigilance regulatory requirements.
- Five years of experience in a drug safety/pharmacovigilance department. Experience of narrative preparation and Medical Dictionary for Regulatory Activities (MedDRA) coding essential. Experience of SUSAR reporting and DSUR preparation desirable.
- Excellent communication skills.
- Team player as well as ability to work on own initiative.
- Versatility and ability to work to deadlines.
- Oncology background/experience an advantage.
- An understanding of the importance of regulatory deadlines.
- Conduct timely review and processing of serious adverse events (SAEs) in accordance with regulations, guidances, Cancer Trials Ireland pharmacovigilance standard operating procedures (SOPs) and contracts on Cancer Trials Ireland sponsored studies and studies where Cancer Trials Ireland has the European sponsor role.
- Focus on timely generation of narratives for non-expedited SAEs.
- Provide back-up for the Pharmacovigilance manager.
Review SAEs received from clinical investigational sites and collaborating organisations.
Acknowledge receipt of SAEs to sites and follow-up for outstanding information. Forward SAEs to a third party if required.
Collaborate with chief investigators and other Cancer Trials Ireland investigators on the medical review of SAEs.
Assess SAEs for seriousness and expectedness. Assign the sponsor causality assessment.
Track SAEs in a safety database. Track other safety data such as suspected unexpected serious adverse reaction (SUSAR) submissions.
Code SAEs as per the MedDRA coding dictionary.
Write a narrative or CIOMS report for SAEs.
Perform quality control checks on the work of pharmacovigilance colleagues.
Update tracking and descriptive documents such as narratives following quality control (QC) by another pharmacovigilance colleague.
Perform expedited reporting of safety data such as SUSARs to competent authorities, ethics committees and investigators including submission onto the Eudravigilance database.
Produce line listings of SUSARs for reporting purposes.
Involvement in the production of annual safety reports (producing the report or performing the QC).
Reconcile SAEs between safety and clinical databases.
Review and assess changes in study-specific reference safety information.
Inform clinical colleagues of SAE queries and provide SAE tracking data on request.
Provide line listings and other safety data for safety review meetings.
Contribute to the review and updating of pharmacovigilance SOPs.
Perform other tasks as specified by line manager/CEO.
Please send your CV to Ide.Fagan@cancertrials.ie
Closing Date: Friday Jan 5th 2018