Pharmacovigilance Services New Associate
Location: Chennai, Tamil Nadu, India
Company: Accenture
Department: Life Sciences R&D – Pharmacovigilance Services
Employment Type: Full-Time
Shift: Rotational Shifts
Role Summary
The Pharmacovigilance Services New Associate is responsible for supporting drug safety and pharmacovigilance activities by processing Individual Case Safety Reports (ICSRs), performing case intake, data entry, MedDRA coding, follow-up activities, and maintaining safety databases in compliance with client requirements and global regulatory guidelines.
This role plays a critical part in ensuring patient safety by contributing to the detection, assessment, monitoring, and prevention of adverse drug reactions and safety risks associated with pharmaceutical products.
Key Responsibilities
Individual Case Safety Report (ICSR) Processing
Perform end-to-end processing of Individual Case Safety Reports (ICSRs).
Review and assess safety information received from various sources.
Ensure timely and accurate case processing in accordance with:
Client Requirements
Global Pharmacovigilance Regulations
Internal Procedures
Maintain compliance with established case processing timelines.
Case Intake & Case Identification
Receive and review adverse event reports from:
Healthcare Professionals
Patients
Clinical Studies
Literature Sources
Regulatory Authorities
Identify reportable safety cases.
Verify completeness of case information.
Escalate incomplete or critical safety information when required.
Data Entry & Safety Database Management
Enter safety information into pharmacovigilance databases.
Ensure accuracy, completeness, and consistency of case data.
Update and maintain case records throughout the lifecycle.
Follow database standards and quality requirements.
MedDRA Coding
Perform medical coding using:
MedDRA (Medical Dictionary for Regulatory Activities)
Code:
Adverse Events
Medical History
Indications
Other Relevant Medical Information
Ensure coding accuracy and consistency with regulatory standards.
Case Follow-Up Activities
Initiate and track follow-up requests for missing information.
Coordinate with relevant stakeholders to obtain additional safety details.
Update case records upon receipt of follow-up information.
Ensure closure of follow-up activities within required timelines.
Drug Safety Surveillance
Support pharmacovigilance activities related to:
Adverse Event Monitoring
Drug Safety Surveillance
Safety Data Collection
Risk Identification
Contribute to patient safety initiatives by ensuring high-quality safety data processing.
Regulatory Compliance
Adhere to:
Global Pharmacovigilance Regulations
Good Pharmacovigilance Practices (GVP)
Company SOPs
Client-Specific Guidelines
Ensure all activities meet regulatory and compliance requirements.
Maintain audit-ready documentation.
Quality & Documentation Management
Ensure quality and completeness of safety case documentation.
Participate in quality checks and process reviews.
Support continuous improvement initiatives.
Maintain confidentiality of patient and safety information.
Team Collaboration
Work collaboratively with:
Pharmacovigilance Teams
Safety Reviewers
Quality Teams
Supervisors
Participate in team meetings and knowledge-sharing sessions.
Escalate issues appropriately when required.
Operational Support
Resolve routine operational issues following established guidelines.
Complete assigned tasks within productivity and quality expectations.
Adapt to changing priorities and business requirements.
Support organizational goals and service delivery commitments.
Required Qualifications
Education
One of the following qualifications:
Bachelor of Pharmacy (B.Pharm)
Bachelor’s Degree in:
Life Sciences
Biotechnology
Microbiology
Biochemistry
Biomedical Sciences
Related Scientific Discipline
Master’s Degree in:
Life Sciences
Biotechnology
Pharmacology
Related Healthcare or Scientific Discipline
Experience
0–1 year of experience in:
Pharmacovigilance
Drug Safety
Clinical Research
Life Sciences Operations
Freshers with strong pharmacovigilance knowledge are encouraged to apply.
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