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Safety Reporting Specialist

Thermo Fisher Scientific
2+ years
Not Disclosed
Remote, India, India
15 Nov. 13, 2026
Job Description
Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

JOB DESCRIPTION: TM – PHARMACOVIGILANCE

COMPANY: Cognizant
JOB TITLE: TM – Pharmacovigilance
JOB ID: 00069806711
DATE PUBLISHED: 6 November 2026
JOB LOCATION: Mumbai, Maharashtra, India
JOB CATEGORY: Technology & Engineering
FUNCTIONAL AREA: Pharmacovigilance / Drug Safety Operations
WORK MODEL: Hybrid
EMPLOYMENT TYPE: As per company requirements


1. ABOUT THE COMPANY – COGNIZANT

Cognizant is a global technology services and consulting organisation that provides digital transformation, engineering, AI and business process solutions to clients across various industries.

The company works with pharmaceutical, healthcare and life sciences organisations to improve business operations through technology, scientific expertise and process innovation.

Its major areas of focus include:

  • Healthcare and Life Sciences.

  • Artificial Intelligence and Digital Transformation.

  • Technology and Engineering.

  • Pharmaceutical Research and Development.

  • Business Process Management.

  • Data Analytics and Automation.

  • Enterprise Technology Solutions.

2. ABOUT THE ROLE

The TM – Pharmacovigilance position focuses on managing and overseeing end-to-end pharmacovigilance operations for global pharmaceutical clients.

The role requires strong knowledge of pharmaceutical research and development, clinical data interpretation, drug safety operations and pharmacovigilance case processing.

The selected candidate will be responsible for ensuring accurate safety data handling, reviewing complex safety cases, monitoring operational quality, supporting regulatory compliance and driving continuous improvement across pharmacovigilance workflows.

The position also involves collaboration with safety physicians, medical reviewers, clinical research teams, data management professionals and global stakeholders.

In addition, the candidate will provide guidance and mentoring to junior pharmacovigilance professionals.

3. EDUCATIONAL QUALIFICATIONS

Preferred educational backgrounds include:

  • B.Pharm – Bachelor of Pharmacy.

  • M.Pharm – Master of Pharmacy.

  • PharmD – Doctor of Pharmacy.

  • B.Sc. – Bachelor of Science in Life Sciences.

  • M.Sc. – Master of Science in Life Sciences.

  • MBBS / MD – Medical qualifications.

  • Other relevant pharmacy, medical or life sciences qualifications.

4. EXPERIENCE REQUIREMENTS

The job description does not specify an exact number of years of experience.

However, the responsibilities indicate a requirement for substantial experience in pharmaceutical research and development and relevant exposure to pharmacovigilance activities.

Expected experience includes:

  • Pharmaceutical Research and Development.

  • Pharmacovigilance case processing.

  • Adverse Event (AE) management.

  • Individual Case Safety Report (ICSR) handling.

  • Safety narrative review.

  • Clinical and post-marketing safety operations.

  • Safety case follow-up.

  • Medical and scientific data interpretation.

  • Quality review of safety documentation.

  • Regulatory compliance.

  • Team coordination and mentoring.

5. KEY ROLES AND RESPONSIBILITIES

A. END-TO-END PHARMACOVIGILANCE OPERATIONS

  • Manage end-to-end pharmacovigilance activities for assigned pharmaceutical clients.

  • Oversee safety case intake and initial evaluation.

  • Ensure accurate safety case documentation.

  • Monitor case processing activities.

  • Ensure timely completion of safety case processing.

  • Manage case follow-up activities.

  • Support case closure within established timelines.

  • Ensure compliance with applicable regulatory requirements.

  • Maintain accuracy and completeness of safety information.

B. PHARMACOVIGILANCE CASE PROCESSING

  • Handle and review pharmacovigilance safety cases.

  • Review adverse event information.

  • Evaluate available patient and product information.

  • Support safety case documentation.

  • Review follow-up information.

  • Ensure consistency between source documents and safety records.

  • Identify missing or inconsistent information.

  • Support accurate processing of clinical and post-marketing safety cases.

C. SAFETY CASE REVIEW AND NARRATIVE QUALITY

  • Review complex pharmacovigilance cases.

  • Validate medical and scientific accuracy.

  • Review safety case narratives.

  • Ensure consistency with source data.

  • Verify clinical information.

  • Check investigational product details.

  • Review study-related information.

  • Ensure compliance with internal procedures and applicable regulations.

  • Identify discrepancies and recommend appropriate corrections.

D. SERIOUSNESS, EXPECTEDNESS AND BENEFIT-RISK ASSESSMENT SUPPORT

Collaborate with medical reviewers, safety physicians and data management teams to support safety case assessments.

Key activities include:

  • Support assessment of case seriousness.

  • Review available information for expectedness assessment.

  • Understand the clinical context of reported adverse events.

  • Support medical and scientific evaluation.

  • Review relevant investigational product information.

  • Understand potential benefit-risk implications.

  • Coordinate with medical reviewers for complex safety cases.

  • Ensure accurate documentation of assessment-related information.

E. CLINICAL AND POST-MARKETING SAFETY OPERATIONS

  • Coordinate with pharmaceutical Research and Development teams.

  • Support integration of safety information across clinical and post-marketing activities.

  • Understand clinical study design.

  • Interpret clinical trial-related safety information.

  • Review investigational product details.

  • Ensure accurate representation of clinical context in safety documentation.

  • Support consistent interpretation of safety data.

F. QUALITY ASSURANCE AND COMPLIANCE

  • Monitor quality standards across pharmacovigilance activities.

  • Review safety documentation for accuracy.

  • Identify process gaps and quality issues.

  • Ensure adherence to Standard Operating Procedures (SOPs).

  • Follow applicable work instructions.

  • Maintain documentation discipline.

  • Support audit and inspection readiness.

  • Respond to audit-related queries.

  • Promote a culture of quality and accountability.

  • Support corrective and preventive actions (CAPA), where applicable.

G. KPI MONITORING AND PERFORMANCE REPORTING

  • Monitor pharmacovigilance operational performance.

  • Track Key Performance Indicators (KPIs).

  • Monitor quality metrics.

  • Prepare regular performance reports.

  • Identify operational performance gaps.

  • Analyse quality trends.

  • Recommend corrective actions.

  • Recommend preventive actions.

  • Support continuous improvement initiatives.

  • Monitor operational efficiency and productivity.

H. PROCESS OPTIMISATION AND CONTINUOUS IMPROVEMENT

  • Identify gaps in pharmacovigilance workflows.

  • Recommend practical process improvements.

  • Support implementation of process enhancements.

  • Improve case processing quality.

  • Enhance operational efficiency.

  • Reduce recurring errors.

  • Support standardisation of safety processes.

  • Promote continuous improvement across safety operations.

I. SAFETY DATABASE AND TECHNOLOGY SUPPORT

  • Work with technology and data management teams.

  • Provide functional feedback on safety case processing tools.

  • Support testing of system enhancements.

  • Identify system-related issues.

  • Support improvements in case processing workflows.

  • Promote effective use of pharmacovigilance databases.

  • Encourage adoption of updated tools and processes.

  • Maintain accurate safety information within relevant systems.

J. STAKEHOLDER MANAGEMENT AND COMMUNICATION

  • Coordinate with global pharmaceutical clients.

  • Communicate with safety physicians.

  • Collaborate with medical reviewers.

  • Work with clinical research teams.

  • Coordinate with data management professionals.

  • Provide regular project status updates.

  • Communicate potential operational risks.

  • Discuss deliverables and timelines.

  • Escalate issues when necessary.

  • Maintain professional communication with global stakeholders.

K. TRAINING AND TEAM MENTORING

  • Guide junior pharmacovigilance professionals.

  • Share pharmacovigilance domain knowledge.

  • Explain pharmaceutical research and development concepts.

  • Provide guidance on safety case processing.

  • Reinforce best practices in safety data handling.

  • Support quality improvement within the team.

  • Encourage knowledge sharing.

  • Help junior professionals understand clinical and scientific information.

6. REQUIRED PHARMACOVIGILANCE KNOWLEDGE

Candidates should have a good understanding of the following areas:

  • Pharmacovigilance fundamentals.

  • Adverse Event (AE) reporting.

  • Individual Case Safety Reports (ICSRs).

  • Safety case intake.

  • Safety case evaluation.

  • Case documentation.

  • Case follow-up.

  • Safety narrative preparation and review.

  • Seriousness assessment.

  • Expectedness assessment.

  • Clinical trial safety.

  • Post-marketing safety.

  • Medical and scientific data interpretation.

  • Benefit-risk assessment.

  • Safety quality review.

  • Regulatory compliance.

  • Audit and inspection readiness.

7. PHARMACEUTICAL RESEARCH AND DEVELOPMENT KNOWLEDGE

This role places particular importance on pharmaceutical Research and Development knowledge.

Candidates should understand:

  • Drug discovery and development.

  • Clinical research.

  • Clinical trial phases.

  • Clinical study design.

  • Clinical trial protocols.

  • Investigational medicinal products.

  • Investigational product information.

  • Clinical trial safety reporting.

  • Clinical and post-marketing safety data.

  • Patient safety monitoring.

  • Clinical data interpretation.

  • Drug benefit-risk evaluation.

8. IMPORTANT REGULATORY AND QUALITY CONCEPTS

Candidates should be familiar with applicable global pharmacovigilance requirements and client-specific standards.

Important concepts include:

  • Good Pharmacovigilance Practices (GVP).

  • Good Clinical Practice (GCP).

  • ICH pharmacovigilance guidelines.

  • ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.

  • ICH E2B – Electronic Transmission of Individual Case Safety Reports.

  • ICH E2D – Post-Approval Safety Data Management.

  • ICH E2E – Pharmacovigilance Planning.

  • Standard Operating Procedures (SOPs).

  • Corrective and Preventive Actions (CAPA).

  • Regulatory reporting timelines.

  • Audit and inspection readiness.

9. REQUIRED TECHNICAL SKILLS

A. SAFETY DATABASES

  • Familiarity with pharmacovigilance safety databases.

  • Ability to enter and review safety case information.

  • Ability to track case processing activities.

  • Knowledge of safety documentation workflows.

  • Understanding of electronic safety data management.

Examples of commonly used industry systems include:

  • Oracle Argus Safety.

  • ArisGlobal LifeSphere MultiVigilance.

  • Veeva Safety.

  • Other client-specific pharmacovigilance databases.

These are examples of industry systems; the job posting does not confirm which specific database Cognizant uses for this position.

B. MICROSOFT OFFICE

  • MS Word.

  • MS Excel.

  • MS PowerPoint.

  • MS Outlook.

C. REPORTING AND ANALYTICS

  • KPI tracking.

  • Quality metrics monitoring.

  • Performance reporting.

  • Data analysis.

  • Operational tracking.

  • Report preparation.

  • Trend identification.

10. REQUIRED SOFT SKILLS AND COMPETENCIES

  • Strong analytical and problem-solving abilities.

  • Excellent written and verbal communication.

  • Strong medical and scientific understanding.

  • Attention to detail.

  • Accuracy in safety documentation.

  • Effective stakeholder management.

  • Team collaboration.

  • Time management.

  • Ability to handle complex safety information.

  • Adaptability to changing requirements.

  • Ability to work independently.

  • Mentoring and leadership skills.

  • Continuous learning and development.

  • Professional handling of confidential patient information.

11. KEY STAKEHOLDERS AND DEPARTMENTS

The selected candidate will collaborate with:

  • PHARMACOVIGILANCE TEAM: Managing safety case processing and operational activities.

  • PHARMA R&D TEAM: Providing clinical and scientific information related to drug development.

  • SAFETY PHYSICIANS: Supporting medical assessment and safety evaluation.

  • MEDICAL REVIEWERS: Reviewing clinical information and safety cases.

  • DATA MANAGEMENT TEAM: Supporting safety data accuracy and consistency.

  • TECHNOLOGY TEAM: Improving safety databases and processing tools.

  • QUALITY TEAM: Monitoring quality standards and compliance.

  • GLOBAL CLIENTS: Coordinating safety deliverables and operational requirements.

12. CERTIFICATIONS AND ADDITIONAL TRAINING

Preferred certifications include:

  • Pharmacovigilance certification from DIA (Drug Information Association).

  • Equivalent pharmacovigilance certification.

  • Advanced training in Clinical Research.

  • Advanced training in Drug Safety.

Additional beneficial training includes:

  • ICH-GCP training.

  • GVP training.

  • ICSR case processing.

  • Clinical trial safety reporting.

  • Medical terminology.

  • Safety narrative writing.

  • Pharmacovigilance quality management.

13. WORKING MODEL

LOCATION: Mumbai, Maharashtra, India.

WORK MODEL: Hybrid.

The selected candidate will follow the organisation's hybrid working arrangements and is expected to maintain productivity, manage time independently and ensure secure handling of confidential clinical and safety information.

14. IDEAL CANDIDATE PROFILE

The ideal candidate should have:

  • A graduate or postgraduate degree in Pharmacy, Life Sciences, Medicine or a related discipline.

  • Substantial pharmaceutical Research and Development experience.

  • Exposure to pharmacovigilance case processing.

  • Experience handling or reviewing safety cases.

  • Knowledge of safety narratives and follow-up activities.

  • Understanding of clinical study design.

  • Knowledge of investigational products.

  • Strong clinical and scientific interpretation skills.

  • Experience with safety databases.

  • Knowledge of global pharmacovigilance regulations.

  • Experience in quality review and process improvement.

  • Strong communication and stakeholder management skills.

15. IMPORTANT JOB DETAILS

 

PARTICULARS

DETAILS

Company

Cognizant

Job Title

TM – Pharmacovigilance

Job ID

00069806711

Date Published

6 November 2026

Job Category

Technology & Engineering

Functional Area

Pharmacovigilance

Location

Mumbai, India

Work Model

Hybrid

Qualification

Graduate / Postgraduate

Experience

Substantial R&D experience expected; exact years not specified

Primary Function

Pharmacovigilance Delivery

Database Knowledge

Safety databases

Preferred Certification

DIA / Equivalent PV Certification

Additional Training

Clinical Research / Drug Safety

16. CAREER OPPORTUNITIES AND LEARNING

This position can provide professional exposure to:

  • Global Pharmacovigilance Operations.

  • Clinical Trial Safety.

  • Post-Marketing Safety.

  • ICSR Case Processing.

  • Complex Safety Case Review.

  • Medical and Scientific Assessment.

  • Safety Quality Management.

  • Regulatory Compliance.

  • Pharmaceutical Research and Development.

  • Safety Database Optimisation.

  • Process Improvement.

  • Team Leadership and Mentoring.

Potential future career opportunities include:

  • Senior Pharmacovigilance Specialist.

  • Pharmacovigilance Team Lead.

  • Drug Safety Specialist.

  • Safety Operations Lead.

  • Pharmacovigilance Quality Specialist.

  • ICSR Quality Reviewer.

  • Clinical Safety Specialist.

  • Safety Management Professional.

  • Pharmacovigilance Project Manager.

17. OVERALL JOB OBJECTIVE

The primary objective of the TM – Pharmacovigilance role is to oversee and improve global pharmacovigilance operations by ensuring accurate safety case processing, scientific data interpretation, regulatory compliance and high-quality safety documentation.

The position combines pharmaceutical Research and Development knowledge with practical pharmacovigilance expertise.

The selected professional will contribute to patient safety by reviewing complex safety cases, coordinating with medical and clinical teams, monitoring quality metrics, improving operational workflows and mentoring junior team members.

18. KEY FOCUS AREAS OF THIS ROLE

  • Global Pharmacovigilance Operations.

  • Pharmaceutical Research and Development.

  • ICSR Case Processing.

  • Adverse Event Management.

  • Safety Case Evaluation.

  • Safety Narrative Review.

  • Clinical Trial Safety.

  • Post-Marketing Safety.

  • Seriousness Assessment.

  • Expectedness Assessment.

  • Benefit-Risk Assessment.

  • Medical Review Coordination.

  • Safety Database Management.

  • GVP and GCP Compliance.

  • KPI and Quality Metrics.

  • Audit and Inspection Readiness.

  • CAPA and Process Improvement.

  • Stakeholder Management.

  • Team Mentoring and Training.