Job Description

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

Requirements

• 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)

Skills Required