Medical Reviewer - Trainee
Location: Mysore (Hybrid)
Department: Drug Safety Services
Employment Type: Full Time
Minimum Experience: Entry-level
Job Title:
Medical Reviewer - Trainee
Company Overview:
Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. With experience across a diverse range of therapeutic areas, Sitero focuses on innovative, technology-enabled solutions that allow clients to concentrate on their core strengths. From early phase studies to Phase III trials, the team ensures safety across the clinical research spectrum, emphasizing ethics, compliance, and innovation.
Function:
Drug Safety
Job Description:
The Medical Reviewer is a key contact for assigned clinical development or marketed products. This role is responsible for executing the safety strategy and producing major safety deliverables across early and late-stage development. The reviewer ensures the ongoing safety and risk management of assigned products and collaborates closely with internal safety teams, CROs, and external partners.
Essential Duties and Responsibilities:
Analyze, review, and interpret non-clinical and clinical safety data.
Conduct medical reviews of ICSRs and drug safety data from various sources (clinical trials, spontaneous/solicited reports, literature).
Provide expert technical and medical input in assessing causality of ICSRs and identifying quality/process improvement opportunities.
Contribute to aggregate safety report preparation, including DSURs and PBRERs, ensuring regulatory compliance.
Support the creation and revision of SOPs, work instructions, and guidance documents.
Assist in developing and delivering safety/pharmacovigilance training programs.
Represent pharmacovigilance at investigator meetings.
Collaborate with Regulatory Affairs for accurate reporting of safety data to regulatory bodies and prescribers.
Act as a subject matter expert for third-party drug safety service vendors.
Mentor Pharmacovigilance Physicians and Specialists.
Ensure adherence to global pharmacovigilance regulations and guidelines (CIOMS, FDA, EMA, PMDA, ICH, etc.).
Education and Experience Required:
Medical Degree (MBBS or higher) from a recognized medical school.
At least 1 year of clinical practice experience required.
0–1 year of experience in Drug Safety/Pharmacovigilance within pharma, biotech, CRO, or regulatory settings is preferable.
Preferred Skills:
Strong understanding of US and EU drug safety regulations, CIOMS, and ICH guidelines.
Experience in medical safety assessments and surveillance activities.
Skilled in ICSR review, including coding (e.g., MedDRA), SMQs, expectedness and causality assessments, and benefit-risk analysis.
Familiarity with safety data from clinical trials, post-marketing sources, literature, and solicited reports.
Strong collaboration, relationship-building, and communication skills.
Innovative, proactive, and team-oriented mindset.
Compensation & Benefits:
Competitive salary
Variable pay
Paid time off
Healthcare and retirement benefits
Employment Type:
Permanent, Full Time
Work Commitments:
Standard: 40 hours/week, Monday to Friday with 1-hour lunch break.
Flexibility to work in shifts when required.
Disclaimer:
Sitero is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other status protected by law.
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