Qualified Person for Pharmacovigilance (QPPV) Specialist

 

Manage PV system for medications

 

 

ESSENTIAL JOB FUNCTIONS : 

 

 

● Involved of the QPPV in the causality assessment, seriousness, submission and follow-up of the

 

 

local ICSRs.

 

 

● Having an overview of medicinal product safety profiles and any emerging safety concerns

 

 

● Having awareness of any conditions or obligations adopted as part of the marketing

 

 

authorizations and other commitments relating to safety or the safe use of the products

 

 

● Having overseen the preparation, quality control, and timely submission of PSURs/PBRERs

 

 

according to SFDA deadlines and requirements.

 

 

● Maintain and update the Pharmacovigilance System Master File (PSMF).

 

 

● Having awareness of risk minimization measures and being aware of and having sufficient

 

 

authority over the content of Risk Management Plan RMPs

 

 

● Having awareness of post-authorization safety studies requested by the SFDA including the

 

 

results of such studies

 

 

● Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related

 

 

documents in accordance with the legal requirements and GVP

 

 

● Having awareness of signal management

 

 

● Ensuring the necessary quality, including the correctness and completeness, of

 

 

Pharmacovigilance data submitted to the SFDA

 

 

● Ensuring a full and prompt response to any request from the SFDA for the provision of

 

 

additional information necessary for the benefit-risk evaluation of a medicinal product

 

 

● Providing any other information relevant to the benefit-risk evaluation to the SFDA

 

 

● Providing input into the preparation of regulatory action in response to emerging safety

 

 

concerns

 

 

● Acting as a single pharmacovigilance contact point for the SFDA on a 24-hour basis and as a

 

 

contact point for pharmacovigilance inspections.

 

 

 

 

 

AUTHORITY: Maintain/Manage PV system - SFDA

 

 

 

 

 

Bachelor’s degree in Pharmacy.

 

 

1–3 years of practical experience in Pharmacovigilance or Drug Safety.

 

 

Professional certifications such as Pharmacovigilance Certification are preferred

 

 

QPPV CERTIFICATE