Soterius is hiring for the position of Senior Associate – Clinical Safety and Pharmacovigilance. The role involves drug safety and pharmacovigilance activities, adverse drug reaction processing, ICSR case processing, project management, quality and compliance, documentation, and stakeholder coordination.
Job Details
| Details | Information |
|---|---|
| Company | Soterius |
| Job Title | Senior Drug Safety Associate |
| Experience | 2–4 Years |
| Location | Noida |
| Employment Type | Full-Time |
| Function | Clinical Safety and Pharmacovigilance |
Position
Senior Associate – Clinical Safety and Pharmacovigilance
The position supports drug safety and pharmacovigilance activities, including processing and reviewing adverse drug reactions, ICSR case processing, regulatory compliance, project ownership, quality management, and safety-related documentation.
Job Responsibilities
- Support drug safety and pharmacovigilance activities as requested by management.
- Record and review adverse drug reactions in safety or other relevant databases for post-marketing and clinical trial reports.
- Ensure adverse event processing meets applicable regulatory standards and client procedures with high accuracy and quality.
- Support development and deployment of assigned technology solutions, including implementation, validation, upgrades, bug fixes, change requests, and product lifecycle support.
- Coordinate with required internal and external stakeholders.
- Support effective functioning of assigned projects, including ICSR case processing and compliance with client agreements, regulations, and guidelines.
- Take ownership of assigned projects and tasks while maintaining timelines and quality.
- Manage quality, compliance, and documentation across assigned projects.
- Identify and communicate concerns or issues that may affect work quality and functioning.
- Support compliance with agreements, applicable regulations, and guidance.
- Train and mentor personnel as required.
- Identify training and development requirements relevant to the function.
- Respond to or represent the department/function during audits and inspections, as required.
- Author and review SOPs and other documents relevant to the department and function.
- Perform other responsibilities assigned by management.
Eligibility / Qualifications
- 2–4 years of experience
- Experience relevant to drug safety and pharmacovigilance activities.
- Experience with adverse drug reaction recording and review.
- Experience with ICSR case processing and compliance activities.
Required Skills
- Drug Safety
- Pharmacovigilance
- Adverse Drug Reaction processing
- ICSR case processing
- Safety database operations
- Clinical trial and post-marketing safety reports
- Regulatory compliance
- Quality and documentation management
- Project ownership and timeline management
- Stakeholder communication
- SOP authoring and review
- Audit and inspection support
- Training and mentoring
- Technology solution support and implementation
Application Details
