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Pharmacovigilance Associate at Novotech Global
Bangalore, karnataka, India -
Full Time

Start Date

Immediate

Expiry Date

29 Jun, 26

Salary

0.0

Posted On

31 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Pharmacovigilance, Clinical Studies, Post-Marketing Surveillance, Safety Mailbox Monitoring, Safety Management Plan, Safety Database Setup, ICSR Processing, ICH-GCP Compliance, Regulatory Requirements, Medical Terminology Coding, Case Processing, Safety Report Submission, English Fluency, Interpersonal Communication, Time Management, Multi-tasking

Industry

Biotechnology Research

Description
PURPOSE OF PHARMACOVIGILANCE ASSOCIATE ROLE: The purpose of the Pharmacovigilance Associate role is to monitor and manage the safety aspects of clinical studies/post-marketing surveillance including but not limited to monitoring safety mailbox, preparation of safety management plan, setting up safety database for studies, processing & submission of ICSRs (SAE/SUSAR/AEs) in accordance with ICH-GCP, SOPs and applicable regulatory requirements/ensure compliance with regulations.
Responsibilities
The Pharmacovigilance Associate monitors and manages safety aspects for clinical studies and post-marketing surveillance, including monitoring the safety mailbox and preparing safety management plans. This role involves setting up safety databases and processing/submitting ICSRs (SAE/SUSAR/AEs) in compliance with regulations and SOPs.