Associate Manager – PV Case Processing
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Job Summary
The Associate Manager – PV Case Processing is responsible for the assessment, processing, review, and regulatory submission of adverse event reports in compliance with global pharmacovigilance regulations and company procedures. The role ensures the accuracy, completeness, quality, and timely submission of safety data while supporting internal and external stakeholders through effective communication and collaboration.
Key Responsibilities
Adverse Event Case Processing
Perform assessment, processing, and management of adverse event (AE) and product complaint reports.
Ensure accurate and timely case processing in accordance with global pharmacovigilance regulations and reporting timelines.
Review source documents and case information to ensure completeness and data quality.
Identify potential case processing issues that may impact regulatory reporting timelines and escalate concerns appropriately.
Data Quality & Compliance
Validate data entered into safety databases against source documentation and call notes.
Ensure adverse event reports meet quality, accuracy, and completeness standards.
Maintain compliance with internal procedures, global regulatory requirements, and pharmacovigilance guidelines.
Support quality review activities and contribute to continuous process improvement initiatives.
Follow-Up & Stakeholder Communication
Obtain follow-up information from healthcare professionals, customers, and other external parties through written and verbal communication.
Collaborate with internal teams and stakeholders to resolve case-related queries and ensure timely completion of case processing activities.
Maintain effective working relationships with colleagues, management, and external partners.
Regulatory Reporting Support
Support the preparation and submission of adverse event reports to regulatory authorities within established timelines.
Monitor case processing activities to ensure compliance with reporting requirements.
Assist in managing safety reporting workflows and regulatory commitments.
Pharmacovigilance Compliance
Stay current with global pharmacovigilance regulations, industry practices, and safety reporting requirements.
Ensure confidentiality and protection of company and patient information.
Support inspections, audits, and compliance-related activities when required.
Required Qualifications
Education
Veterinarian (equivalent to a US DVM degree), with or without Pharmacovigilance experience; OR
Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field with relevant Pharmacovigilance experience.
Experience
4–7 years of experience in Pharmacovigilance, Drug Safety, or Case Processing.
Experience in adverse event case processing, data review, and regulatory reporting.
Familiarity with global pharmacovigilance regulations and safety databases.
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