PV Associate

Clinigen • Full-time • Pretoria, Gauteng, South Africa • 3d ago

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 ICSRs
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 ICSRs
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

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.

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)

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