15 Nov '21
Pharmacovigilance Specialist

Medical, Gauteng Gauteng


A Global Pharmaceutical Company has a vacancy for a Pharmacovigilance Specialist.

Job Purpose:
The PV Specialist is responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring. They are also responsible for PV activities (as delegated or assigned by their Manager) which may include but are not limited to: PV intake, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, local training, communication of safety issues and/or special projects as assigned and is able to work on these delegated activities independently.

Key Responsibilities:

  • Oversees all daily PV processes and activities within the countries covered by the country operation as required. 
  • Establishes and coordinates reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislation's
  • Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements. 
  • Acts in full compliance with global and local SOP's and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
  • Participates in and supports audits of contractual partners/vendors as necessary. 
  • Supports PV Lead in maintaining the local PV Training matrix and on-boarding plans.
  • Supports training of local PV staff, company personnel, distributors, vendors, and business partners in the countries covered by the country operation and can provide training as applicable.
  • Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation.
  • Supports local initiatives (e.g. digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.
  • Participates on local company committees and councils (as appropriate) for matters impacting PV as assigned.

  • The incumbent must have a health, life science (Hons degree preferred for life sciences), or medical science degree and be fluent in English (written and spoken).
  • They should have a minimum of?1-3 ?years of pharmaceutical industry experience, preferably in pharmacovigilance.
  • He/she must have knowledge of PV regulations for countries covered by the country operation and have knowledge of PV?processes and activities.
  • The PV Specialist is expected to have excellent communication and time management skills, the ability to interface broadly?with colleagues within related functions and cross-functionally and be able to well work independently and in teams.

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.

Ad Visible Until: 30 December 2021
Ref: DBN002985/SS

Vacancy Type: Permanent