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Manager - Pharmacovigilance Department

7 - 11 years

0 Lacs

hyderabad telangana

Posted:2 days ago| Platform: Shine logo

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Skills Required

project management communication regulatory compliance data entry query resolution reconciliation training mentoring rmp signal detection metrics tracking ae case review workflow procedures aggregate reporting quality reviewing

Work Mode

On-site

Job Type

Full Time

Job Description

As a Project Lead, your responsibilities will include leading and managing projects, supervising all project-related activities, and facilitating communication between the Project Manager and the team. You will be tasked with recording, maintaining, and tracking metrics for both team members and project performance. Additionally, you will review and evaluate AE case information to determine required actions based on internal policies and procedures. Your role will also involve processing current incoming cases to meet Regulatory timelines, providing guidance for data entry, following up with sites regarding outstanding queries, and addressing reconciliation discrepancies. It is essential to adhere to departmental AE workflow procedures and train and mentor new team members as per project requirements. Moreover, you will be expected to author/draft aggregate reports and quality reviews such as PBRER, PSURs, PADER, Addendum to Clinical Overviews, RMP, and Signal detection reports. The ideal candidate should have 7-10 years of relevant experience and hold a qualification of MBBS/MD/M.Pharm. This position is based in Hyderabad.,

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Jeevan Scientific Technology Limited

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