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Senior Drug Safety Scientist

Accenture
7-11 years
Not Disclosed
Bengaluru, India
15 Nov. 13, 2026
Job Description
Job Type: Full Time, Hybrid 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: SENIOR DRUG SAFETY SCIENTIST

COMPANY: Accenture
JOB TITLE: Senior Drug Safety Scientist
JOB ID: AIOC-S01653591
JOB LOCATION: Bengaluru, Karnataka, India
JOB CATEGORY: Pharmacovigilance Operations
SKILL REQUIRED: Pharmacovigilance & Drug Safety Surveillance
DESIGNATION LEVEL: Pharmacovigilance Services Team Lead / Consultant
EMPLOYMENT TYPE: Full Time
EXPERIENCE REQUIRED: 7–11 Years (as specified in detailed job description)
JOB HEADING EXPERIENCE: 5–10 Years
QUALIFICATIONS: Bachelor of Pharmacy (B.Pharm) / MBBS


1. ABOUT THE COMPANY – ACCENTURE

Accenture is a global professional services organisation providing technology, consulting and business operations solutions across multiple industries.

The company supports pharmaceutical and healthcare organisations through its Life Sciences Research and Development (R&D) services.

Its major service areas include:

  • Clinical Research Services.

  • Pharmacovigilance Operations.

  • Regulatory Affairs.

  • Patient Services.

  • Life Sciences Technology.

  • Clinical Trial Support.

  • Drug Safety Surveillance.

2. ABOUT THE ROLE

The Senior Drug Safety Scientist position focuses on managing pharmacovigilance operations and overseeing Individual Case Safety Report (ICSR) processing for global pharmaceutical clients.

The selected candidate will work within Accenture's Life Sciences R&D vertical, particularly the Clinical, Pharmacovigilance and Regulatory sub-offering.

The role involves handling complex pharmacovigilance activities, analysing safety information, resolving moderately complex operational problems, ensuring regulatory compliance and supporting team management.

Unlike an entry-level Drug Safety Associate position, this role requires greater independence, problem-solving ability, operational ownership and the ability to manage small teams or work efforts.

3. EDUCATIONAL QUALIFICATIONS

Mandatory qualifications mentioned in the job description:

  • B.Pharm – Bachelor of Pharmacy.

  • MBBS – Bachelor of Medicine and Bachelor of Surgery.

4. EXPERIENCE REQUIREMENTS

Experience specified in the detailed job description: 7–11 years.

The job heading mentions 5–10 years, so candidates should confirm the applicable experience requirement with the recruitment team.

Relevant experience areas include:

  • Pharmacovigilance Operations.

  • Drug Safety Surveillance.

  • ICSR Case Processing.

  • Complex Safety Case Management.

  • MedDRA Coding.

  • Safety Case Evaluation.

  • Case Submission.

  • Case Follow-up.

  • Regulatory Compliance.

  • Pharmacovigilance Quality Management.

  • Team Management and Operational Leadership.

5. KEY ROLES AND RESPONSIBILITIES

A. END-TO-END PHARMACOVIGILANCE OPERATIONS

  • Manage pharmacovigilance activities for assigned pharmaceutical clients.

  • Oversee safety case processing activities.

  • Ensure accurate and timely processing of ICSRs.

  • Monitor case processing workflows.

  • Ensure compliance with client-specific guidelines.

  • Follow applicable global regulatory requirements.

  • Identify operational challenges.

  • Support continuous improvement in pharmacovigilance operations.

B. ICSR CASE IDENTIFICATION

  • Identify potential Individual Case Safety Reports.

  • Review incoming safety information.

  • Evaluate patient and reporter information.

  • Identify suspected medicinal products.

  • Identify reported adverse events.

  • Verify minimum criteria for valid ICSRs.

  • Identify potential duplicate cases.

  • Ensure appropriate case identification according to established procedures.

C. ICSR DATA ENTRY AND PROCESSING

  • Perform safety case data entry.

  • Review patient information.

  • Document reporter details.

  • Record medicinal product information.

  • Document adverse event details.

  • Review relevant medical history.

  • Ensure accurate case documentation.

  • Maintain consistency between source documents and database information.

  • Ensure timely completion of case processing activities.

D. MEDDRA CODING

  • Perform MedDRA coding of adverse events.

  • Identify appropriate medical terminology.

  • Select relevant Lowest Level Terms (LLTs).

  • Map reported terms to Preferred Terms (PTs).

  • Ensure appropriate System Organ Class (SOC) classification.

  • Review coding accuracy.

  • Resolve coding discrepancies.

  • Follow MedDRA coding conventions.

E. SAFETY CASE EVALUATION AND REVIEW

  • Review complex safety cases.

  • Analyse available clinical and medical information.

  • Identify inconsistencies in case data.

  • Verify safety case completeness.

  • Review adverse event information.

  • Ensure consistency between source documents and safety narratives.

  • Identify missing information.

  • Resolve moderately complex case processing issues.

  • Escalate cases requiring specialised medical assessment.

F. ICSR SUBMISSION MANAGEMENT

  • Ensure processed cases are prepared for submission.

  • Support regulatory submission activities.

  • Monitor case submission timelines.

  • Follow applicable global reporting requirements.

  • Maintain submission-related documentation.

  • Ensure compliance with client-specific submission procedures.

  • Track submission status.

  • Support timely completion of regulatory deliverables.

G. CASE FOLLOW-UP MANAGEMENT

  • Manage follow-up activities for safety cases.

  • Identify missing safety information.

  • Prepare follow-up requests where required.

  • Monitor pending follow-up responses.

  • Update cases with newly received information.

  • Ensure follow-up documentation is maintained.

  • Monitor case timelines.

  • Support completion of follow-up activities.

H. PROBLEM-SOLVING AND PROCESS IMPROVEMENT

  • Analyse moderately complex pharmacovigilance problems.

  • Identify process-related gaps.

  • Develop appropriate solutions.

  • Adapt existing procedures when required.

  • Recommend operational improvements.

  • Support implementation of process enhancements.

  • Improve case processing efficiency.

  • Reduce recurring errors.

  • Contribute to quality improvement initiatives.

I. REGULATORY COMPLIANCE AND QUALITY

  • Ensure adherence to global pharmacovigilance requirements.

  • Follow client-specific SOPs.

  • Maintain accurate safety documentation.

  • Monitor case processing quality.

  • Ensure compliance with regulatory timelines.

  • Identify discrepancies and quality issues.

  • Support audit and inspection readiness.

  • Promote adherence to established procedures.

  • Maintain patient confidentiality.

J. TEAM MANAGEMENT AND OPERATIONAL LEADERSHIP

  • Manage small teams or assigned work efforts.

  • Coordinate pharmacovigilance activities.

  • Support junior team members.

  • Monitor team deliverables.

  • Provide operational guidance.

  • Support task allocation and prioritisation.

  • Monitor performance and productivity.

  • Escalate operational issues.

  • Support achievement of team objectives.

  • Align team activities with senior management's strategic direction.

K. CLIENT AND STAKEHOLDER MANAGEMENT

  • Interact with pharmaceutical clients.

  • Coordinate with internal pharmacovigilance teams.

  • Communicate with supervisors and management.

  • Participate in operational discussions.

  • Provide updates on assigned deliverables.

  • Discuss process-related challenges.

  • Support resolution of client-related issues.

  • Maintain professional stakeholder relationships.

6. IMPORTANT PHARMACOVIGILANCE KNOWLEDGE

Candidates should have strong knowledge of the following:

A. PHARMACOVIGILANCE FUNDAMENTALS

  • Pharmacovigilance principles.

  • Adverse Drug Reactions (ADRs).

  • Adverse Events (AEs).

  • Serious Adverse Events (SAEs).

  • Suspected Unexpected Serious Adverse Reactions (SUSARs).

  • Drug Safety Surveillance.

  • Clinical Trial Safety.

  • Post-Marketing Surveillance.

B. ICSR CASE PROCESSING

  • Case intake.

  • Case identification.

  • Minimum criteria for valid ICSR.

  • Case creation.

  • Data entry.

  • MedDRA coding.

  • Medical review.

  • Narrative preparation.

  • Quality review.

  • Case submission.

  • Follow-up.

  • Case closure.

C. SERIOUSNESS ASSESSMENT

Understand the six major seriousness criteria:

  1. Death.

  2. Life-threatening condition.

  3. Hospitalisation or prolongation of existing hospitalisation.

  4. Persistent or significant disability or incapacity.

  5. Congenital anomaly or birth defect.

  6. Other medically important medical events.

D. MEDDRA CODING

  • System Organ Class (SOC).

  • High Level Group Term (HLGT).

  • High Level Term (HLT).

  • Preferred Term (PT).

  • Lowest Level Term (LLT).

  • Coding conventions.

  • Medical terminology selection.

E. SAFETY CASE QUALITY

  • Source data verification.

  • Case completeness.

  • Duplicate case identification.

  • Narrative quality.

  • Medical terminology accuracy.

  • Data consistency.

  • Quality control.

  • Follow-up documentation.

7. IMPORTANT REGULATORY GUIDELINES

The following regulatory guidelines are important for this position:

  • ICH E2A – Clinical Safety Data Management.

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

  • ICH E2D – Post-Approval Safety Data Management.

  • ICH E2E – Pharmacovigilance Planning.

  • Good Pharmacovigilance Practices (GVP).

  • Good Clinical Practice (GCP).

  • Applicable global Health Authority reporting requirements.

  • Client-specific pharmacovigilance SOPs.

8. PHARMACOVIGILANCE DATABASE KNOWLEDGE

Experience with safety databases is beneficial.

Examples of commonly used industry systems include:

  • Oracle Argus Safety.

  • ArisGlobal LifeSphere MultiVigilance.

  • Veeva Safety.

Important activities include:

  • Safety case creation.

  • ICSR data entry.

  • MedDRA coding.

  • Case processing.

  • Case assessment support.

  • Case follow-up.

  • Submission tracking.

  • Case quality review.

  • Database documentation.

The specific database used for this Accenture project is not mentioned in the job description.

9. REQUIRED TECHNICAL SKILLS

  • Advanced understanding of pharmacovigilance operations.

  • ICSR case processing.

  • MedDRA coding.

  • Drug safety surveillance.

  • Safety case evaluation.

  • Regulatory submission.

  • Case follow-up management.

  • Safety database operations.

  • Quality management.

  • Regulatory compliance.

  • Process improvement.

  • Operational reporting.

  • Team coordination.

10. REQUIRED SOFT SKILLS

  • Strong analytical skills.

  • Problem-solving ability.

  • Decision-making.

  • Leadership.

  • Team management.

  • Client communication.

  • Stakeholder management.

  • Attention to detail.

  • Time management.

  • Independent working ability.

  • Adaptability.

  • Conflict resolution.

  • Effective communication.

  • Ability to manage multiple responsibilities.

11. ROLE AND RESPONSIBILITY LEVEL

This position involves a higher level of responsibility compared with entry-level pharmacovigilance positions.

The selected candidate is expected to:

  • Solve moderately complex problems.

  • Develop solutions using existing methods and procedures.

  • Understand strategic team objectives.

  • Work with supervisors and management.

  • Interact with client representatives.

  • Make decisions that can affect team performance.

  • Manage small teams or individual work efforts.

  • Work independently with guidance on new assignments.

12. WORKING CONDITIONS

 

PARTICULARS

DETAILS

Company

Accenture

Job Title

Senior Drug Safety Scientist

Job ID

AIOC-S01653591

Location

Bengaluru, Karnataka

Employment

Full Time

Experience

7–11 Years (detailed description)

Qualification

B.Pharm / MBBS

Primary Skill

Pharmacovigilance Operations

Secondary Skill

Drug Safety Surveillance

Designation Level

Team Lead / Consultant

Work Shifts

Rotational shifts may be required

13. IDEAL CANDIDATE PROFILE

The ideal candidate should possess:

  • B.Pharm or MBBS qualification.

  • 7–11 years of relevant professional experience as per the detailed requirements.

  • Strong pharmacovigilance operational knowledge.

  • Experience in ICSR case processing.

  • Good understanding of MedDRA coding.

  • Experience in safety case evaluation.

  • Knowledge of global regulatory reporting requirements.

  • Experience with safety databases.

  • Strong analytical and problem-solving abilities.

  • Experience managing operational responsibilities.

  • Ability to guide and coordinate team members.

  • Strong client and stakeholder communication skills.

14. IMPORTANT INTERVIEW PREPARATION TOPICS

Candidates preparing for this position should focus on:

  1. End-to-end pharmacovigilance processes.

  2. ICSR case processing workflow.

  3. Minimum criteria for valid ICSR.

  4. Serious and non-serious adverse events.

  5. Seriousness and expectedness assessment.

  6. MedDRA hierarchy and coding.

  7. Complex case processing.

  8. Narrative writing and quality review.

  9. Duplicate case management.

  10. Follow-up management.

  11. Regulatory reporting timelines.

  12. ICH guidelines.

  13. GVP and GCP.

  14. Safety database management.

  15. Case reconciliation.

  16. Pharmacovigilance quality management.

  17. Process improvement and CAPA.

  18. Team management and workload allocation.

  19. Client communication and stakeholder management.

  20. Handling operational escalations.

15. CAREER GROWTH OPPORTUNITIES

This position can provide exposure to senior-level pharmacovigilance operations and team management.

Potential future career opportunities include:

  • Senior Drug Safety Scientist.

  • Pharmacovigilance Team Lead.

  • Pharmacovigilance Operations Manager.

  • Drug Safety Project Manager.

  • Pharmacovigilance Quality Manager.

  • ICSR Operations Lead.

  • Drug Safety Consultant.

  • Global Pharmacovigilance Manager.

16. OVERALL JOB OBJECTIVE

The primary objective of the Senior Drug Safety Scientist position is to ensure effective delivery of pharmacovigilance operations for global pharmaceutical clients.

The selected candidate will oversee ICSR case identification, data entry, MedDRA coding, case processing, submission and follow-up activities while ensuring compliance with client-specific procedures and global regulatory requirements.

The role combines technical pharmacovigilance expertise, complex problem-solving, process improvement, stakeholder management and team leadership to support patient safety and high-quality drug safety surveillance.