Location: Mysore, Karnataka (Hybrid)
Department: Drug Safety Services
Employment Type: Full Time, Permanent
Company Overview
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We specialize in innovative, technology-enabled solutions, offering a wide range of therapeutic areas. Our focus is on ensuring the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: Drug Safety Associate (DSA)
Job Description
The Drug Safety Associate is responsible for assessing the safety of pharmaceutical drugs undergoing clinical trials or those already in the market. Using standard guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings to regulatory bodies and health authorities.
The role involves collaborating with safety teams within Sitero and partners, maintaining medical knowledge, and having a strong understanding of drug safety, pharmacovigilance regulations, and risk management practices.
Essential Duties and Responsibilities
Analyze, review, and interpret safety data from non-clinical and 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 reports from post-marketing surveillance studies.
Identify duplicate/invalid ICSRs.
Process cases from clinical trials, literature, spontaneous reports, market research, social media, and solicited cases for both serious and non-serious reports.
Enter data for all subject information into EDC databases as required.
Conduct peer reviews and quality reviews of cases and EDC data entries.
Send queries for clarity associated with incoming information if required.
Ensure accurate and consistent coding of events, drugs, procedures, indications, and laboratory tests using appropriate dictionaries (e.g., MedDRA, Company Product Dictionary, WHO-DD).
Ensure case narratives contain correct and appropriate safety information.
Ensure timely processing and submission of cases according to service level agreements.
Contribute to safety and pharmacovigilance training programs.
Collaborate with Regulatory Affairs for appropriate reporting to regulatory agencies and the prescriber community.
Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
Train and mentor Pharmacovigilance Associates.
Education and Experience Required
Minimum 1+ year of experience in drug safety or clinical research domain.
Degree in Life Science/Pharma or equivalent.
Preferred Skills
Awareness of safety databases and scientific coding browsers such as MedDRA and WHO.
In-depth knowledge and understanding of drug safety/pharmacovigilance regulations.
Strong organizational, documentation, and interpersonal skills for effective interaction with clients, management, peers, and cross-functional teams.
Good working knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
Experience with safety data collection and interpretation from clinical trials and other sources (literature, solicited, and post-marketing environment).
Ability to build relationships, collaborate, and influence across disciplines within Sitero and with outside stakeholders.
Excellent verbal, written, and presentation skills.
Innovative, collaborative, and proactive.
Compensation & Benefits
Sitero offers an impressive compensation package and benefits, including a competitive salary, variable pay, paid time off, and healthcare and retirement benefits.
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