PV Associate

3 days ago

Pretoria, South Africa Clinigen Full time

For the Company Working within the Pharmacovigilance Operations team Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database Support quality and efficiency strategies within the organisation Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits as required Contributes to improvements of team processes. Other PV operational activities or initiatives as assigned Maintaining good client relations and ensuring a consistently high quality of work for each client. Review of Medical Information Enquiries and Product Quality Complaints to ensure all safety information has been captured. For the Clients Managing mailboxes – responding to data entry / case processing queries from Clients and Client Partners, providing responses Triage, tracking and forwarding of safety data from client Managed Access Programmes. Distribution of SUSARs to enrolled physicians within MAP as per agreement with client. Case processing of SAEs and/or ICSSRs Case regulatory reporting; preparing relevant cases for submission and sending to the relevant Regulatory Authorities Working on E2B/R3 format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgments. Supporting investigation of cases of non-compliance of SAEs/ICSRs Performing Literature Article reviews Performing follow-up related to queries and requests regarding case handling Communicating with Clients and/Partners regarding the evaluation and processing of ICSSRs Performing quality-control of cases in the Global Drug Safety database Performing reconciliation activities as per Client contracts and each Client Operating Guideline (COG) Assists when required in Partner, Health Authority Audits/Inspections. Participation in Client audits and inspections Qualifications Healthcare Professional qualification or equivalent of a Batchelor of Science (BSc) degree Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities Excellent organizational and prioritization skills and strong analytical / problem solving skills Excellent oral and written communication skills Ability to build relationships with key internal and external customers Excellent attention to detail and ability to work under pressure Extensive knowledge of MS Office Applications and systems Outstanding written, verbal, and interpersonal communication skills Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment Proven ability to work collaboratively within a matrix and/or cross-functional environment Self-motivated and organised, with the ability to work unsupervised for periods of time Excellent analytical thinking, with the ability to evaluate and present complex safety data applying sound judgement. Benefits Annual Leave - 20 days per year Sick Leave - 30 days (3 year cycle) Family Responsibility Leave - 3 days per year Company Medical Aid Contribution - R2 200 per month (Discovery, Medihelp or Momentum) Discretionary company bonus 13th Cheque in Dec (Prorated par start date) GroupLife (Disability Cover, Death Benefit and Funeral Cover) #J-18808-Ljbffr

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