Patient Safety Associate II / Patient Safety Specialist
MohaliContract2–5 yrsPosted over a month ago
Mid-level operations contract role at Parexel International India safety services in Mohali. Needs 2+ years and a degree.
About the role
We are seeking a Patient Safety Associate II/Specialist to join our Patient Safety Operations team in a Temporary assignment (Contract role for 9 months) for on-site capacity. As a Patient Safety Associate II/Specialist, you will support global pharmacovigilance activities that advance new treatments for patients.
What you'll do
- Monitor, process, and assess incoming safety reports from various sources
- Execute safety case processing workflows including MedDRA coding, causality assessment, expectedness determination, and preparation of case documentation and narratives
- Execute ICSR and periodic report submissions to regulatory authorities, maintaining compliance with global reporting timelines and regulatory requirements
- Implement literature search strategies, screen publications for adverse drug reactions, identify potential safety signals
- Support communication and coordination between global safety operations and local affiliates
What you need
- Reporting
- Pharmacovigilance
- Clinical research
- Data analysis
- Microbiology
- SOP writing
Good to have
- Regulatory affairs
- Reconciliation