Pharmacovigilance

4 weeks ago

Amaravati Andhra Pradesh, India Thepharmadaily Full time
Job Description

- Ensure compliance with applicable regulations and standard operating procedures in pharmacovigilance processes.
- Specialize in drug safety management, clinical trials, and medical supervision.
- Conduct, monitor, and report regular pharmacovigilance developments, overseeing processes related to drug effectiveness and adverse effects avoidance.
- Aim to reduce risks associated with drug administration and prescribing, improving safety and treatment outcomes in patient care.
- Perform important case report follow-up, process adverse event programs, and serve as a link between the company, healthcare experts, and patients to deliver valid information on product safety.
- Conduct and supervise regular pharmacovigilance processes, attend product safety meetings, and enhance product safety functionality.
- Monitor all products and conduct post-market evaluations to ensure drug safety, assess adverse event writings, update safety reports, and convey drug-related case reports to appropriate authorities.
- Play a crucial role in research, development, and testing of new medications in the pharmaceutical industry.
- Handle global pharmacovigilance activities, support data safety and case tracking, perform document archiving, assist in administering pharmacovigilance meetings, and support quality review of documents.
- Draft pharmacovigilance agendas and meeting minutes, accurately archive documents, review safety case data for completeness and accuracy, monitor periodic safety reports, and assist with tracking, submitting, and distributing periodic reports.
- Support liaisons with partners and cross-functional team members to ensure compliance, handle ad-hoc deliverables or pharmacovigilance projects, and assist with regulatory inspections.

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