Specialist, Pharmacovigilance Epidemiology & Risk Management

2 - 6 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be responsible for performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial, and literature cases. Your role will involve data entry into the PV database, preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files), and submission of ICSRs to Health Authorities and partners of a client. Additionally, you will conduct quality checks of Individual Case Safety Reports (ICSRs) to ensure compliance with industry standards and best practices. Key Responsibilities: - Performing triage and review for initial validity assessment of cases - Data entry into PV database - Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files) - Submission of ICSRs to Health Authorities and partners of a client - Conducting quality checks of Individual Case Safety Reports (ICSRs) Qualifications Required: - Prior experience in pharmacovigilance or a related field - Knowledge of safety reporting requirements and regulations - Strong attention to detail and ability to maintain compliance with industry standards - Excellent communication and organizational skills Note: The company offers benefits that may vary by country and align with local market practices. Equal employment opportunity principles are followed, and reasonable accommodations are provided to individuals with disabilities during the employment process upon request. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. Accommodation determinations will be made on a request-by-request basis.,

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Cencora

Pharmaceutical logistics and supply chain

New York

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