Mitcon Biopharma Pharmacovigilance QA, Project Management Vacancies at Hyderabad
Urgent Openings for Pharmacovigilance Quality Assurance(PVQA) Manager & Project Management
Location: Begumpet, Hyderabad
Qualification: Life science background.
Experience:5-6yrs
Should be interested to relocate to Hyderabad 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.
Communicates with partner companies and vendors
regarding processing and timely exchange of safety data. Distributes aggregate reports as required and assists with reconciliation activities. Develop/improve and manage quality systems and processes to include; Creation/revision of appropriate SOPS.
Urgent Openings for Project Management Operations – Pharmacovigilance.
Experience: 5-6yrs
Location: Begumpet, Hyderabad
Qualification: Any Life science Background.
Worked as a member in PMO (project management office), prepared monthly reconciliations and compliance reports.
Actively involved in client communications, initiated kick off meetings, project initiation, regular follow-up meetings, prepared meeting slides.
Performed ICSR processing (as QR) of spontaneous and literature cases. Case processing in Argus, Clinevo safety databases and Safety Reporting Portal (SRP).
Triage, duplicate search and case book-in of ICSRs.
Submission of ICSRS via Argus and Clinevo databases to
various regulatory authorities using XMLS and E2B transmission (to EMA, MHRA and PvPI etc). Submission of cases to US FDA via SRP.
Downloading EMA obligation reports and processing them in Eudravigilance. Performed Medical Literature Monitoring (MLM) activities using PubMed, Springer Embase databases.
Performed aggregate reporting (PADERS) and generation of line listings in Argus and Clinevo databases.
To coordinate with MICC team and initiate necessary
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 [email protected]
