Sitero LLC, a rapidly growing global clinical services and software solutions company, is hiring Drug Safety Associate and Drug Safety Associate – Trainee professionals for its Drug Safety Services team in Mysore, Karnataka. These full-time permanent roles offer an excellent opportunity for pharmacovigilance professionals to work on global clinical trials and post-marketing safety surveillance in compliance with US, EU, and ICH guidelines.
This is an ideal opportunity for candidates with experience in drug safety, pharmacovigilance, or clinical research who are looking to build a long-term career in a technology-enabled CRO environment.
Open Positions (Hiring for 2 Roles)
- Drug Safety Associate (DSA)
- Drug Safety Associate – Trainee
Key Responsibilities – Drug Safety Associate Jobs
- Perform end-to-end case processing of Individual Case Safety Reports (ICSRs) within regulatory timelines
- Conduct initial assessment of adverse events from clinical trials and post-marketing sources
- Process safety cases from clinical trials, literature, spontaneous reports, social media, and solicited sources
- Identify duplicate and invalid ICSRs
- Ensure accurate MedDRA and WHO-DD coding for events, drugs, indications, and lab tests
- Prepare high-quality case narratives with complete safety information
- Perform peer review and quality review of safety cases and EDC data
- Collaborate with Regulatory Affairs for timely submissions to global health authorities
- Send and resolve data clarification queries
- Support pharmacovigilance training and mentor junior associates
- Act as a subject matter expert for vendors and partners
Qualifications & Experience Required
- Education: Degree in Life Sciences / Pharmacy or equivalent
- Experience:
- Drug Safety Associate: Minimum 1+ year experience in drug safety or clinical research
- Drug Safety Associate – Trainee: Entry-level candidates with pharmacovigilance knowledge may apply
- Strong understanding of pharmacovigilance regulations
- Familiarity with ICSR processing, CIOMS, ICH, US FDA, and EU regulations
Preferred Skills & Competencies
- Hands-on experience with drug safety databases
- Knowledge of MedDRA, WHO-DD, and safety coding tools
- Experience in clinical trial and post-marketing safety data analysis
- Excellent documentation, communication, and interpersonal skills
- Ability to collaborate across cross-functional and global teams
- Willingness to work in shifts as required
Salary, Benefits & Work Type
- Salary Range: ₹4,00,000 – ₹7,00,000 per annum (CTC, based on role & experience)
- Employment Type: Full-Time, Permanent
- Benefits Include:
- Competitive salary with variable pay
- Paid time off
- Health insurance & retirement benefits
- Exposure to global pharmacovigilance projects
Job Location
📍 Mysore, Karnataka, India
How to Apply
Application Link for Drug Safety Associate
Application Link for Drug Safety Associate Trainee
