Pharmacovigilance Reporting Specialist
Skills
About the role
This is a pharmacovigilance reporting role at ICON plc, preparing safety reports for pharmaceutical and clinical trial products. It suits someone with prior drug safety experience who is comfortable with regulatory reporting, and it is based in Chennai, India, with other listed office options. ICON is a clinical research and healthcare intelligence organization.
What you’ll do
- Prepare and submit periodic safety update reports (PSURs) and individual case safety reports (ICSRs)
- Analyze safety data to identify trends and assess product safety profiles
- Collaborate with cross-functional teams on timely adverse event reporting
- Maintain current knowledge of pharmacovigilance regulations and best practices
- Train and support team members on reporting processes
What they’re looking for
- Bachelor's degree in a relevant scientific or healthcare-related field
- Significant experience in pharmacovigilance reporting or drug safety in a clinical or pharmaceutical setting
- Strong analytical skills with data analysis and reporting tools
- Strong communication and interpersonal skills
What’s on offer
- Annual leave entitlements
- Health insurance offerings
- Retirement planning offerings
- Global Employee Assistance Programme (LifeWorks)
- Life assurance
- Country-specific optional benefits
Questions about this role
Is this role remote?
The posting lists it as remote or office, with Chennai as one of several listed locations.
Do I need a degree?
Yes, a bachelor's degree in a relevant scientific or healthcare-related field is required.
What experience is needed?
Significant experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment.
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