Pharmacovigilance Services Associate
Company: Accenture
Location: Bengaluru, India
Department: Life Sciences R&D – Pharmacovigilance Services
Job Type: Full-Time
Experience: 0–2 Years
JOB OVERVIEW
The Pharmacovigilance Services Associate is responsible for supporting global drug safety and pharmacovigilance activities by processing Individual Case Safety Reports (ICSRs), performing MedDRA coding, evaluating adverse events, maintaining safety databases, and ensuring compliance with global pharmacovigilance regulations. The role involves case identification, data entry, quality review, follow-up activities, and safety surveillance to ensure timely and accurate reporting of adverse events.
KEY RESPONSIBILITIES
ICSR Case Processing
Identify, validate, and process Individual Case Safety Reports (ICSRs).
Perform case intake, booking, and duplicate checks.
Evaluate source documents for reportable safety information.
Process clinical trial and post-marketing adverse event cases.
Ensure timely case completion within regulatory timelines.
Safety Data Entry
Enter safety data into pharmacovigilance databases accurately.
Extract information from source documents.
Maintain complete and accurate case documentation.
Update case information throughout the processing lifecycle.
Ensure compliance with client SOPs and global guidelines.
MedDRA Coding
Perform MedDRA coding for adverse events.
Code medical history and concomitant medications.
Ensure coding consistency and accuracy.
Follow global coding standards.
Review coded terms before case completion.
Adverse Event Assessment
Assess seriousness, causality, and expectedness of adverse events.
Review product labeling during safety assessment.
Escalate potential safety concerns to Medical Reviewers.
Support ongoing safety monitoring activities.
Document assessment outcomes accurately.
Case Narrative Development
Prepare and update medical case narratives.
Document company comments and causality assessments.
Ensure narratives meet client quality standards.
Maintain consistency with regulatory requirements.
Support regulatory submissions with complete documentation.
Follow-up Activities
Identify missing safety information.
Initiate follow-up requests when required.
Track pending follow-up cases.
Update cases with newly received information.
Maintain follow-up communication records.
Quality Assurance
Perform self-quality checks before case submission.
Conduct validation and consistency reviews.
Correct identified discrepancies.
Ensure compliance with quality metrics.
Maintain high data accuracy and productivity.
Regulatory Compliance
Follow global pharmacovigilance regulations and client guidelines.
Prioritize cases based on TAT, SLA, KPIs, and regulatory deadlines.
Support safety signal monitoring activities.
Archive case-related communications.
Ensure inspection-ready documentation.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)
EXPERIENCE REQUIREMENTS
Required
0–2 years of Pharmacovigilance or Drug Safety experience
Preferred
1–3 years of experience in ICSR Processing
Experience with Pharmacovigilance Safety Databases
Experience in MedDRA Coding
Knowledge of Global Drug Safety Regulations
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Canada |Quebec :
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