Sitero is an emerging leader in Clinical Services and Software Solutions for the life sciences industry. With a strong focus on innovative and technology-enabled solutions, Sitero delivers unparalleled value to its clients, ensuring compliance, ethics, and safety. From early-phase studies to Phase III clinical trials, Sitero offers expertise in diverse therapeutic areas, empowering stakeholders to focus on their core strengths. The company’s experienced teams emphasize delivering high-touch services that ensure the safety and efficiency of the clinical research community.
Job Title: Drug Safety Associate (DSA)
Location: Mysore, Karnataka (Hybrid)
Function: Drug Safety
Employment Type: Full-Time, Permanent
Job Description
The Drug Safety Associate (DSA) plays a critical role in assessing the safety of pharmaceutical drugs undergoing clinical trials or those already in the market. DSAs evaluate data to determine any adverse drug reactions and report findings to regulatory bodies and health authorities. The ideal candidate will work closely with safety professionals, Contract Research Organizations (CROs), and stakeholders, ensuring compliance with pharmacovigilance regulations and safety practices.
Key Responsibilities
- Analyze, review, and interpret safety data from clinical and non-clinical sources, including literature.
- Perform end-to-end case processing of Individual Case Safety Reports (ICSRs) to meet regulatory timelines.
- Evaluate spontaneously reported adverse events, including those from post-marketing surveillance studies.
- Identify duplicate/invalid ICSRs to ensure data accuracy.
- Handle case processing from multiple sources: clinical trials, literature, spontaneous reports, market research, social media, and solicited cases.
- Accurately perform data entry into EDC databases for subject information.
- Conduct peer reviews and quality checks of safety cases and data entered into systems.
- Send and manage queries for clarity regarding incoming safety data.
- Code events, drugs, procedures, indications, and lab tests using dictionaries like MedDRA and WHO-DD.
- Ensure case narratives are accurate, complete, and aligned with regulatory requirements.
- Deliver high-quality safety case submissions within stipulated timelines.
- Contribute to pharmacovigilance training programs and regulatory compliance initiatives.
- Act as a subject matter expert for vendors providing drug safety services.
- Collaborate with Regulatory Affairs for reporting pharmacovigilance data to regulatory agencies.
- Mentor and train junior Pharmacovigilance Associates as needed.
Qualifications
- A degree in Life Science, Pharma, or an equivalent field.
- Minimum of 1+ years of experience in Drug Safety, Pharmacovigilance, or Clinical Research.
Skills
- In-depth knowledge of Drug Safety and Pharmacovigilance regulations.
- Familiarity with safety databases, MedDRA, WHO-DD, and other scientific coding browsers.
- Strong understanding of US and EU drug safety regulations, ICH guidelines, and CIOMS.
- Experience in safety data collection and interpretation, including literature and post-marketing reports.
- Exceptional organizational and documentation skills with attention to detail.
- Excellent verbal, written, and presentation skills.
- Strong collaborative, innovative, and problem-solving mindset.
- Ability to work efficiently with cross-functional teams and external stakeholders.
- Willingness to adapt to shifts and work schedules as required.
Compensation & Benefits
Sitero offers a competitive compensation package, including:
- Attractive salary and variable pay.
- Paid time off (PTO).
- Comprehensive healthcare and retirement benefits.
Work Schedule
- Standard work hours: 40 hours/week (Monday to Friday), with a one-hour lunch break.
- Flexibility to work additional hours or shifts as required.
