Drug Safety Associate/Senior Drug Safety Associate – Literature
Company:
Sitero LLC
About Sitero:
Sitero LLC is a leading provider of clinical services and software solutions in the life sciences industry. We deliver innovative, technology-enabled solutions across various therapeutic areas, ensuring compliance, ethics, and safety throughout clinical trials and research phases.
Position Name:
DSA/Sr. DSA – Literature
Organization:
Sitero
Qualifications:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience:
- 1-8 years
Salary:
- ₹25,000 – ₹35,000 per month
Location:
- Mysore, Karnataka (Hybrid)
Essential Duties and Responsibilities:
- Facilitate effective cooperation with clients in literature monitoring.
- Ensure literature screening activities comply with global regulations and company policies.
- Assist in developing literature search strategies.
- Perform literature screening to identify potential ICSRs and other safety-related information.
- Maintain records and track all literature abstracts screened and full articles reviewed.
- Forward ICSRs to PV Associates for data entry into the global drug safety database.
- Perform peer review QC of abstracts.
- Access and download MLM search and MLM ICSR results from EV daily.
- Track MLM search results, MLM ICSRs list downloads, and exported ICSRs.
- Keep the EMA MLM Literature Screening Tracker updated.
- Assist in regulatory inspection preparedness and participate in PV inspections or audits.
Education and Experience Required:
- Minimum 1 year of relevant experience in Literature Screening or Literature case processing.
- Degree in Life Science/Pharma or equivalent.
Preferred Skills:
- 2+ years of experience in drug safety or clinical research.
- Awareness of safety databases and scientific coding browsers like MedDRA, WHO, etc.
- In-depth knowledge of drug safety/pharmacovigilance regulations.
- Strong organizational, documentation, and interpersonal skills.
- Good working knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
- Experience with safety data collection and interpretation from various sources.
- Ability to build relationships and collaborate across disciplines.
- Excellent verbal, written, and presentation skills.
- Innovative, collaborative, and proactive.
Compensation & Benefits:
- Competitive salary
- Variable pay
- Paid time off
- Healthcare
- Retirement benefits
Commitments:
- Standard hours: 40 hours per week, Monday – Friday.
- Willingness to work in shifts as needed.
How to Apply:
Interested candidates can apply through our website or contact our HR department for more details.