Trainee- Specialist, Pharmacovigilance

World Courier

0 - 1 years

3 - 6 Lacs

noida

Posted:14 hours ago| Platform:

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Skills Required

quality standards compliance pharma xml clinical trials pharmacovigilance case processing risk management operations data entry

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Details

Responsibilities:

Conduct triage and initial validity assessments of adverse event cases from multiple sources, including spontaneous reports, health authority notifications, clinical trials, and published literature
Perform accurate and timely data entry into pharmacovigilance databases
Complete initial Individual Case Safety Report (ICSR) assessments in accordance with regulatory requirements
Evaluate case criteria to determine expedited reporting obligations to Health Authorities and client partners, ensuring compliance with applicable reporting timelines
Prepare standardized regulatory reporting forms, including CIOMS I form, MedWatch forms, and XML file formats
Develop and transmit follow-up requests to obtain additional case information as needed
Ensure thorough case documentation and completion in compliance with quality standards
Conduct ICSR searches and retrieval from the EVWEB database, performing company/non-company assessments for case processing
Undertake additional responsibilities as assigned by the supervisor based on operational and process requirements.

Educational Qualification:

B. Pharma, M. Pharma, BDS, Life Science Graduate

Skills:

Excellent communication skill
Attention to detail and ability to work under regulatory timelines
Familiarity with pharmacovigilance processes and reporting standards (preferred)

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