Job Title: Team Lead, PV
Location: Gurgaon, Haryana, India
Job Category: Patient Safety
Date Posted: 04/10/2025
Company Overview:
At Baxter, we are united by a mission to save and sustain lives. Our products and therapies are found in nearly every hospital worldwide, and for over 85 years, we have pioneered significant medical innovations that improve healthcare globally. Working at Baxter means you’ll feel a sense of purpose, knowing that your contributions improve outcomes for millions of patients. Join us at the intersection of saving lives and advancing healthcare, where your work accelerates our mission.
Position Summary:
The Team Lead, PV will be part of the Safety Operations team within Global Patient Safety (GPS). This role will manage the collection, documentation, and processing of local adverse event (AE) reports, ensuring compliance with national legislation and Baxter’s internal procedures. The Team Lead will oversee daily operations, serve as a facilitator between management and team members, and act as a subject matter expert in pharmacovigilance (PV) activities. The ideal candidate will be responsible for mentoring, performance management, and staffing of the assigned team.
Key Responsibilities:
Adverse Event (AE) Management:
Oversee the collection, documentation, and processing of local AE reports from all sources.
Ensure compliance with national regulations and Baxter’s procedures for AE processing.
Perform surveillance activities for new safety information and escalate per procedures.
Conduct local case triage, including validity assessments, duplicate checks, and forwarding to relevant internal and external partners.
Pharmacovigilance Case Processing:
Perform case intake within the Pharmacovigilance Safety System (PSS).
Respond to queries from the global case processing team and provide expertise when needed.
Source document redaction and ensure all documentation is captured in PSS.
Quality and Compliance:
Perform local quality checks to ensure adherence to quality standards and compliance.
Manage Health Authority case downloads as required.
Team Management:
Lead and manage daily operations of assigned staff.
Provide direct oversight, including mentoring, performance management, and staffing.
Qualifications:
Strong experience in pharmacovigilance (PV) and adverse event reporting.
Proven ability to manage a team and oversee daily operations in a fast-paced environment.
In-depth knowledge of national legislation related to patient safety and adverse event reporting.
Expertise in working with Pharmacovigilance Safety Systems (PSS).
Excellent communication skills, with the ability to provide mentorship and manage team performance.
Strong attention to detail and ability to manage compliance and quality checks.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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