This Dublin based Pharmaceutical giant focuses their efforts on producing specialty and branded products that treat a wide range of indications across a varied patient base. With over 100 products available in over 150 different countries, you will be working in a fast-paced environment with a patient-centric outlook on the industry. The company boasts a warm, diverse, multicultural environment where collaboration is paramount.
The PV Team Leader is responsible for oversight and coordination of case assignments whilst also driving a large team of PV Specialists and PV Associates towards set Key Performance Indicators. The PV Team Leader will also liaise effectively with PV Quality Management and Compliance Manager at the Dublin site to document deviations from SOP's with regards to case processing.
- Lead PV team to ensure day-to-day coordination and management of case processing
- Mentor and assist junior PV team members in use of the database, case processing and expediting reports
- Drive PV compliance targets across team
- Review and triage cases
- Review, advise and approve relevant local guidelines, policies, internal procedures and SOPs across affiliates
- Manage safety related requests and ensure requests are answered accurately and promptly
- Ensure regulatory reporting on adverse events is completed within strict time-lines
Education and Skills
- Life Sciences Degree or equivalent.
- Documented experience in all aspects of Pharmacovigilance (2 years minimum).
- Experience writing aggregate safety reports e.g. ASRs, DSURs, PSURs is desirable.
- Experience working with MedDRA coding dictionary.
- Database entry and manipulation for Safety Database.
- Pharmacovigilance practice and procedure
As PV Team Leader, you will be detail oriented, with the ability to multi-task whilst still maintaining the highest level of accuracy in your work. You will be a highly organised, approachable leader with excellent communication skills and the ability to solve problems through your own initiative
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To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales