On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Associate.
To provide support of the Pharmacovigilance operations, in particular for medical & scientific functions with regard to the safety evaluations of all products across company affiliate companies for which marketing authorisations are held.
-Delegation of tasks from QQPV on an ad-hoc basis. Flexibility and time management skills are required. Tasks will also include replacement of any absent member at meetings.
-Review and advise on relevant local & global guidelines, policies, Internal Procedures and SOPS across company affiliate companies.
- Case processing in the global database ArisG, in accordance with company SOPS and regulatory requirements. Tasks include data entry, narrative writing, review & assessment of SAE/AE reports from clinical trial and post marketing sources
-Review cases and request follow up when necessary
-Ensure Good Documentation Practice
-Maintain awareness of Pharmacovigilance regulatory requirements and development
-Contribute to agreed PV Team compliance targets
-Maintain ongoing contacts across all Affiliate companies and gain maximum benefit for the business from scientific affairs
-Support the PV Team with the creation of safety reports such as ICSRs, DSURs, PSURs, regulatory dossiers and quality control activities
Keep abreast of changes and development in PV regulations
-Excellent written and oral communication
-Excellent planning and organising skills
Ability to maintain rigorous adherence to written procedures, SOPS
Excellent attention to detail
Accurate and methodical
Ability to negotiate and influence
Impeccable teamwork skills
Qualifications and Experience
- Life sciences/biological sciences graduat
- Approx 1 years experience in this area
- Competent medical terminolog
- Excellent communication skillsGood IT skills
- Previous use of ARISg database is desirable
For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail Ldunne@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671