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Sr. Specialist PV

Sr. Specialist PV

Baxter

5 - 8 years

7 - 10 Lacs

gurugram

Posted:6 days ago| Platform:

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Skills Required

meddra compliance monitoring reconciliation mentor healthcare manager quality control pharmacovigilance subject matter expert data entry recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

This is where your work makes a difference.

At Baxter, we believe every person regardless of who they are or where they are from deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job you will find purpose and pride.

This position is a member of the Safety Operations team within Global Patient Safety (GPS). This position serves as a subject matter expert for individual case safety report processing and /or Quality control for adverse event reports to ensure timely and accurate review, processing, quality control, and reporting.

Essential Duties and Responsibilities include:

Process adverse event reports from a variety of source types (literature or non-literature based on certification) including review and full data entry of adverse event reports determining seriousness, expectedness, reporter s causality, and overall event resolution
Ensure that the correct suspect drug was selected within the Pharmacovigilance Safety System
Write narratives summarizing all relevant medical information for individual case safety reports
Code medical terms using standardized medical dictionaries (i.e. MedDRA)
Using medical expertise, ensure that all data has been entered and coded correctly in the Global Safety Database
Request case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters in conjunction with local affiliates
Perform quality checks both in line and retrospectively as needed
May perform case cleanup as required for preparation of aggregate reports
May participate in compliance monitoring related activities including CAPA and Quality Control Metrics
May perform reconciliation activities with organizations both within Baxter and outside of Baxter
Train and mentor new hires
Other duties as assigned

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Sr. Specialist PV