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Primevigilance logo

PV Officer, Team Leader

2 - 5 years

4 - 7 Lacs

Pune

Posted:3 days ago| Platform: Naukri logo

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Skills Required

Biotechnology Chemistry Clinical trials Healthcare Workflow Pharmacovigilance Case processing Management Veterinary biomedical

Work Mode

Work from Office

Job Type

Full Time

Job Description

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them. The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc. ) and have demonstrated experience in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion. Responsibilities include: Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review. Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations) Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc. ) Mentoring and training of new and more junior employees within the department, including procedure optimization and development

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Primevigilance
Primevigilance
www.primevigilance.com

Pharmaceutical Services

Chicago

51-200 Employees

6 Jobs

    Key People

  • Samir K. Khosla

    Chief Executive Officer

  • Santiago Martínez

    Chief Operating Officer

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