Hobson Prior are looking for a PV Specialist to join a leading global biopharmaceutical company that has been inventing for life for more than a century. This position is responsible for the day-to-day case management activities within the countries covered by the country operation including compliance with PV processes and regulations and policies and procedures.
- Accountable for day-to-day adverse experience case management within the countries covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
- Responsible for the reconciliation of adverse events reports received from other operating units and contractual partners.
- File, store and archive safety-related data in accordance with policies and local requirements.
- Responsible for being compliant with local PV regulations, policies and procedures and Global Safety procedures at the country level.
- Contribute in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the countries covered by the country operation.
- Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
- Recognise and communicate potential safety issues to PV Country Lead.
- Assist in the delivery of training and mentoring PV staff as applicable.
- Assist in the delivery of training to PV staff and customer facing non-PV staff and distributors/ vendors / business partners in the countries within scope.
- Complete and document required PV training within the required timelines.
- Excellent written & spoken communication skills.
- Proficient in local language.
- Proficient in Good Documentation Practices.
- Strong communication and time management skills and can work independently with minimal supervision.
- Must have a health, life science, or medical science degree or equivalent by education / experience. A minimum 1 year of pharmaceutical industry experience.
- Must have an awareness of Pharmacovigilance regulations within his/her assigned countries.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.