Analyst – Pharmacovigilance (PV)
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Job Summary
The Analyst – Pharmacovigilance (PV) is responsible for the processing, assessment, review, and management of adverse event reports in compliance with global pharmacovigilance regulations and company procedures. This role supports safety data management activities, regulatory reporting, case quality review, and collaboration with internal and external stakeholders to ensure accurate and timely pharmacovigilance operations.
Key Responsibilities
Adverse Event Case Processing
Perform data entry, review, and processing of adverse event reports within the Pharmacovigilance database.
Conduct seriousness, causality, and reportability assessments of adverse event cases.
Identify and escalate case processing issues that may impact reporting timelines.
Ensure compliance with internal procedures and global pharmacovigilance requirements.
Process adverse event and product complaint reports within established timelines.
Case Quality & Data Review
Validate data entered into safety systems against source documents and call notes.
Perform self-quality review to ensure completeness, accuracy, and consistency of case information.
Verify that cases are submission-ready and compliant with applicable regulatory requirements.
Determine and document required follow-up information for incomplete cases.
Maintain expected productivity and quality performance standards.
Global Pharmacovigilance Support
Develop and maintain knowledge of global pharmacovigilance regulations and reporting requirements.
Support global pharmacovigilance activities and collaborate with internal stakeholders as needed.
Manage global adverse event mailboxes and safety communications.
Assist with regulatory submissions of individual case safety reports (ICSRs).
Participate in team meetings and departmental initiatives.
Stakeholder Communication & Collaboration
Communicate effectively with affiliate offices, call centers, legal teams, customer support groups, and other stakeholders.
Collaborate with pharmacovigilance colleagues and cross-functional teams to ensure smooth case processing operations.
Maintain confidentiality of patient, product, and company information.
Ensure compliance with confidentiality agreements before sharing sensitive information with external parties.
Compliance & Continuous Learning
Stay current with pharmacovigilance regulations, industry standards, and best practices.
Support quality, compliance, and inspection-readiness activities.
Contribute to process improvement initiatives and team objectives.
Perform additional pharmacovigilance-related duties as assigned.
Required Qualifications
Education
Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Nursing, Medicine, or a related scientific discipline.
Experience
0–2 years of experience in Pharmacovigilance, Drug Safety, Clinical Research, or related fields.
Freshers with strong pharmacovigilance knowledge may also be considered.
Basic understanding of adverse event case processing and safety reporting concepts.
Technical Skills
Basic knowledge of pharmacovigilance principles and adverse event reporting.
Understanding of medical terminology and clinical concepts.
Familiarity with case processing workflows and regulatory requirements.
Strong data entry, review, and documentation skills.a
Uttar Pradesh :
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Frank Scottile Blvd |Missouri :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
Montreal |Brussels :
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Greece |North Island :
Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
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Ho Chi Minh City |Italy :
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South Africa | Midrand |Nišava District :
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Prague |Chile :
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