Manager/Sr. Manager – Pharmacovigilance

003 Ground Floor, Plot 17/18, Supreme Chambers, Shah Industrial Estate, Off Veera Desai Road, Andheri (West) Mumbai-400053. 

Tel. No. 022-26739198 

JOB DESCRIPTION  

Role – Pharmacovigilance  

Responsibilities: 

Aggregate Safety Reports (Major Function) 

• Thorough understanding and adherence to aggregate safety reporting processes and procedures.  

• Author/review aggregate reports like PSUR & PBRER for submission to DCGI, NDA Uganda, TMDA Tanzania, Maldives, Kenya, Trinidad, Zambia, Oman regulatory bodies and ensure for quality check of scientifically correct and consistent medical information.  

• Develop and validate Risk Management Plan (RMP) for the assigned products.  

• Assess the risk-benefit of a product and identify any gaps in the aggregate documents. 

• Maintain compliance with regulatory timeline(s). 

Individual Safety Case Reports (ICSRs) 

• Execute activities in the scope of ICSR management unit within agreed extent and time-frame. 

• Prepare ICSRs based on the information received on adverse reaction observed with Aristo product. 

• Determine and perform appropriate case follow-up, including generation of reply, dissemination of information & clarifications to the reporter, QA, etc. as required 

• Perform ICSR follow-up activities with reporters, CRO, QC, etc. 

• Manage submission of ICSR in the appropriate format (E2B XML) to regulatory authorities. 

Drug Safety Monitoring 

• Perform day-to-day operational activities of the Safety system & ensure compliance to SOPs and applicable regulations.  

• Responsible for scientific evaluation of safety information and the continuous monitoring of the benefit-risk profile of all Aristo products throughout all stages of the product lifecycle.  

• Provide support for the handling processes pertaining to adverse events and product complaints. 

• Interact with the concerned stakeholders for the purpose of safety data collection and data reconciliation. 

• Provide inputs to Service providers in reconciliation of safety information exchanges with the partners/internal departments/CROs periodically. 

• Updation and maintenance of Pharmacovigilance System Master File (PSMF). 

• Assist in the development and updating of SOPs for PV system. 

• Contribute to the development and fulfilment of CAPAs. 

• Conduct and support PV training activities. 

P.S.

1. The website of Aristo is www.aristopharma.co.in 
2. The candidates should carry photograph and certificates on the day of interview.