Urgent Openings at MITOCON BIOPHARMA for Pharmacovigilance Quality Assurance & Aggregate reporting Roles

Urgent Openings at MITOCON BIOPHARMA for Pharmacovigilance Quality Assurance & Aggregate reporting Roles

8 April, 2022


1. Drug safety associate-Pharmacovigilance Quality Assurance
Experience: 2-3yrs
Qualification: Pharma D/Bpharma/Mpharma
Location: Begumpet, Hyderabad
Should be interested to relocate to Hyderabad.
Experienced in “Drafting of CAPA, Deviations, Work instruction. etc
Perform quality assurance (QA) activities related to FDA and ROW regulations across therapeutic areas and provide regulatory guidance for all phases of drug development.
Supports the oversight and management of global business partner safety data exchange agreements/pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity.

2. Aggregate reporting, pharmacovigilance
Experience: 4-5yrs in aggregate reporting.
Location: Hyderabad
Designation: Assistant Manager
Prepare periodic safety reports on products that are in development (DSUR, IND Annual Report) or that have been granted regulatory approval (PADERs, PSURs and PBRERs, Signals etc.).
To generate ICSRs and Product complaints line listings as per the project requirement.
Analyse and present the clinical and safety data on benefit- risk assessment in documents.
Safety data collection and consolidation for report preparation.
Narrative writing and review.
Perform quality control activities to ensure complete and accurate information has been documented.
Support in preparation of submission readiness of aggregate reports.

Interested candidates kindly call on 9154383165call timings 10:00a.m to 06:00p.m (No Calls on Saturdays and Sundays) or share your resume to hr@mitoconbiopharma.com

Contact person: 
Keerthi Boga
Assistant Manager-HR

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