The Pharmacovigilance Specialist is responsible for the day-to-day case management activities within the country(ies) covered by the country operation, including compliance of the PV processes and regulations and Company policies and procedures. He/she is able to function independently in the processing of adverse events.
This includes the procedural responsibilities in the areas of:
- Adverse experience case management including HA submissions
- Aggregate safety report, health authority submissions and health authority submission compliance for individual case safety reports
- As requested by the PV Country Lead, the PV Specialist may undertake other additional activities, including projects
- Assist in the delivery and training to PV staff and customer facing non-PV staff (e.g. sales representatives, medical information etc.) and distributors/vendors/business partners in the country(ies) within scope
- Complete and document required PV training within the required timelines
- The incumbent must have a health-, life science- or medical science degree or equivalent education/experience
- He/she should have at least 1 year pharmaceutical industry experience
- He/she must have an awareness of Pharmacovigilance regulations
- Strong communication and time management skills
- Ability to work independently with minimal supervision
Candidates that meet the criteria may submit their CV to jane@mnarecruitment com
Should you receive no response within 7 days, please consider your application unsuccessful
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