The Patient Safety Associate II supports global pharmacovigilance activities across clinical trials and post-marketed projects, executing safety processes under supervision. Responsibilities may include case processing, regulatory submissions, literature surveillance, affiliate coordination, and safety intelligence, depending on project needs. The Associate follows international and local regulations, internal procedures, and quality standards, while working collaboratively within cross-functional teams to deliver safety deliverables.
- Key Accountabilities:
General
- Develop knowledge of safety profiles, labeling, and global regulations
- Follow project-specific procedures and workflows
- Support compliance with regulatory reporting timelines
- Assist with audit and inspection preparation as directed
- Review basic metrics and participate in improvement initiatives
- Identify potential issues and report to supervisors
- Follow documentation and archiving procedures
- Participate in training and process implementation
- Support client interactions under supervision




- Work with team members on safety deliverables
- Support recent team members as needed

ICSR processing

Monitor incoming reports from various sources (mailboxes, EudraVigilance, literature)
- Follow established safety procedure implementation
- Perform data entry of valid cases into safety databases
- Validate the accuracy of expectedness, causality assessment, and seriousness criteria for reported events, Execute basic ICSR processing workflows under supervision
- Prepare case documentation including narratives
- Ensure MedDRA coding according to standards
- Support generation of routine safety reports and listings
- Initiate translation requests when required. Review source documents for medical consistency and cohesiveness.
- Conduct quality and validation checks to ensure accuracy.
- Request follow-up and perform query management as applicable
- Follow compliance activities and assist with metrics coll

📌 Patient Safety Associate Ii (Sahibzada Ajit Singh Nagar)
🏢 Parexel
📍 Sahibzada Ajit Singh Nagar