Data Officer – Pharmacovigilance (Safety & Vigilance)
Company: ProductLife Group (PLG)
Location: India (Remote Work Possible)
Department: Life Cycle – Safety & Vigilance
Employment Type: Permanent Contract
Experience Required: Minimum 2 Years
Salary Package
Expected CTC: ₹5 LPA – ₹10 LPA (Estimated market range based on pharmacovigilance case processing experience, regulatory knowledge, database expertise, and organization. Actual compensation may vary.)
Job Summary
The Data Officer – Pharmacovigilance is responsible for safety case data entry, Individual Case Safety Report (ICSR) management, regulatory submissions, database monitoring, and pharmacovigilance documentation activities. The role supports global safety operations by ensuring accurate processing, quality compliance, and timely reporting of adverse event information according to regulatory requirements.
Key Responsibilities
ICSR Data Entry & Case Management
Perform accurate data entry of pharmacovigilance cases into relevant safety databases.
Review and process ICSRs according to company procedures and client requirements.
Prepare initial follow-up emails and requests for additional information or clarification.
Support case quality checks and ensure completeness and accuracy of safety data.
Monitor case status and follow up on pending information within defined timelines.
Regulatory Submission Activities
Submit safety cases to applicable regulatory authorities within required timelines.
Monitor and download ICSRs from national safety databases, including:
EudraVigilance
MHRA Portal
Support regulatory reporting activities and maintain submission tracking records.
Perform database queries to generate safety reports and support pharmacovigilance activities.
Safety Database & Regulatory Documentation
Maintain and update product information records in XEVMPD.
Perform database searches and data extraction for reporting requirements.
Draft and update:
Technical Agreements
Safety Management Plans
Client-specific templates
SOPs
Work Practice Documents (WPDs)
Training materials
Maintain accurate documentation related to pharmacovigilance activities.
Process Improvement & Team Collaboration
Participate in implementation, maintenance, and improvement of pharmacovigilance processes.
Support continuous quality improvement initiatives.
Collaborate with internal teams and clients to ensure timely delivery of safety activities.
Maintain compliance with global pharmacovigilance standards.
Required Qualifications
Bachelor's degree in:
Pharmacy
Life Sciences
Industrial Biology
Chemistry Engineering
Related scientific discipline
Minimum 2 years of pharmacovigilance experience within a service provider, CRO, pharmaceutical company, or safety operations environment.
Experience in:
PV data entry
ICSR processing
Case quality control activities
Experience working with strict regulatory timelines and deadlines.
Required Skills
Strong understanding of pharmacovigilance principles and adverse event reporting.
Knowledge of:
EU Pharmacovigilance Regulations
Good Pharmacovigilance Practices (GVP)
Good Clinical Practice (GCP)
FDA safety reporting requirements
Understanding of:
Adverse event reporting processes
Causality assessment principles
Medical terminology
Experience with pharmacovigilance databases preferred.
Strong documentation and process-oriented approach.
Good computer skills and ability to work with safety systems.
Excellent organizational and time management skills.
Ability to work independently and as part of a team.
Flexible approach with attention to detail.
Excellent written and verbal communication skills in English.
Preferred Skills
Experience with safety databases such as Oracle Argus, ArisGlobal, or similar PV systems.
Knowledge of EudraVigilance and MHRA reporting processes.
Experience supporting global pharmaceutical clients.
Familiarity with XEVMPD and regulatory product data management.
Experience preparing SOPs, WPDs, and safety management documentation.
Career Opportunity
Opportunity to work with global pharmacovigilance operations.
Exposure to EU and international safety regulations.
Experience supporting pharmaceutical clients across product lifecycle activities.
Remote work flexibility with a global life sciences organization.
Growth opportunities in Safety Operations and Pharmacovigilance.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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China | Quarry Bay |Liaoning :
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Queensland |Melbourne :
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Peru | Argentina |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Manila |Croatia :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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