PHARMACOVIGILANCE SERVICES NEW ASSOCIATE
Company: Accenture
Location: Bengaluru, India
Job ID: AIOC-S01638753
Department: Life Sciences R&D – Pharmacovigilance Services
Employment Type: Full Time
JOB OVERVIEW
The Pharmacovigilance Services New Associate will support drug safety and pharmacovigilance activities by performing Individual Case Safety Report (ICSR) processing, case identification, data entry, MedDRA coding, case submission, and follow-up activities. The role focuses on ensuring compliance with global pharmacovigilance regulations and client requirements while maintaining high standards of quality and patient safety.
KEY RESPONSIBILITIES
• ICSR Case Processing
Create and manage Individual Case Safety Reports (ICSRs).
Perform case identification and case intake activities.
Enter adverse event data into safety databases accurately.
Conduct MedDRA coding of adverse events and medical information.
Process safety cases according to client guidelines and global regulations.
Manage case follow-up activities and ensure timely completion.
Support case submissions to regulatory authorities.
• Pharmacovigilance Operations
Monitor adverse event reports and drug safety information.
Ensure compliance with pharmacovigilance regulations and company procedures.
Maintain data quality and consistency in safety databases.
Assist in safety surveillance and monitoring activities.
Support drug safety and risk management processes.
• Compliance & Quality
Follow applicable SOPs, work instructions, and regulatory requirements.
Ensure accuracy, completeness, and quality of safety data.
Maintain documentation according to client and regulatory standards.
Adhere to timelines and productivity requirements.
• Team Collaboration
Work closely with team members and supervisors.
Participate in training and knowledge-sharing activities.
Escalate issues and concerns appropriately.
Support continuous process improvement initiatives.
• Daily Operations
Solve routine pharmacovigilance-related problems using established procedures.
Execute assigned tasks under supervision and guidance.
Contribute as an individual team member within a structured work environment.
Work in rotational shifts as required.
REQUIRED QUALIFICATIONS
Bachelor of Pharmacy (B.Pharm)
Freshers or candidates with up to 1 year of experience can apply.
EXPERIENCE
0–1 Year of Experience
Fresh graduates in Pharmacy.
Internship or project exposure in Pharmacovigilance is advantageous.
Basic understanding of drug safety and adverse event reporting preferred.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
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Remote, India | Siliguri |Illinois :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Auckland |New Zealand :
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Croatia |Zagreb :
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