Pharmacovigilance Management Specialist

Pharmacovigilance Management Specialist
Sector: Pharmaceutical Industry
Location: Johannesburg
Reference: PMS - JHB - MK
 
Our Pharmaceutical Industry client has an employment opportunity for an experienced Pharmacovigilance Management Specialist. You will be responsible to review, prepare, and complete reports on adverse drug experiences, and determine the safety profile of the products and to meet regulatory/ compliance requirements. Create safety report data as required and ensure to submit timeously.
 
Qualification / Experience Requirements, but not limited to:
    • Degree in Life Science or other similar suitable degree preferred
    • 1 to 2 years minimum experience gained in pharmacovigilance/drug safety
    • Competence to solve problems and to surface issues constructively independently and with supervision  
    • Medical writing experience will be advantageous  
    • Management of relational databases will be advantageous
    • Experience in similar position gained in pharmaceutical manufacturing industry
    • Ensure suitable case follow-up, including creation of follow-up requests
    • Ensure to evaluate processed cases and confirm correctness, consistency and compliance of the process requirements, and evaluate case data for special scenarios
    • Liaise with all stakeholders on the subject of safety data collection and data reconciliation
    • Ensure to continuously develop and maintain expertise on applicable corporate and global regulations relating to  guidelines, SOP's, data entry conventions, and search functions in safety database
    • Ascertain reportability of scheduled reports , ensure adherence to regulatory requirements
    • Partake, as required, in safety activities
    • Perform case processing activities
    • Review, maintain, and update SOP's and document case information with the various criteria
    • Review case criteria to determine appropriate workflow for case processing
    • Evaluate cases to differentiate complexities and specific issues, and escalate appropriately
    • Ensure to document case report accordingly  
Please apply to response@mvgrecruitment.co.za  or call 0860 100 684 to enquire.
 
Required supporting documents to accompany CV:
* Copy of ID
* Copy of Qualification/s including Matric