Medical Reviewer - Trainee
Department:
Drug Safety Services
Employment Type:
Full-Time
Minimum Experience:
Entry-level
Location:
Bangalore, Karnataka (Hybrid)
Description:
The Medical Reviewer - Trainee acts as a key contact for assigned clinical development or marketed products, overseeing safety strategies and major safety deliverables for both early and late-stage development projects. The individual manages cross-functional assessments of the benefit-risk profile and communication of safety information for assigned products. As a part of Sitero's safety team, the trainee will collaborate with internal and external stakeholders, maintaining strong knowledge of drug safety regulations, pharmacovigilance practices, and risk management processes.
Essential Duties and Responsibilities:
Analyze, review, and interpret non-clinical and clinical safety data.
Perform medical review of ICSRs and drug safety information from multiple sources including clinical trials, spontaneous and solicited reports, and literature reports.
Provide technical and medical expertise in causality assessment of ICSRs and support quality assessment within the ICSR process.
Contribute to the generation of aggregate safety reports such as DSURs and PBRERs, offering medical input to ensure regulatory compliance.
Assist in developing Standard Operating Procedures, Work Instructions, and guidance documents.
Support and contribute to internal safety and pharmacovigilance training programs.
Provide safety training during investigator meetings.
Collaborate with Regulatory Affairs to ensure appropriate pharmacovigilance reporting to regulatory agencies and healthcare providers.
Serve as a subject matter expert (SME) for vendors providing pharmacovigilance services.
Mentor Pharmacovigilance Physicians and Specialists.
Maintain compliance with global PV regulations and guidelines (e.g., CIOMS, FDA, EMA, ICH).
Education and Experience Required:
Medical Degree (MBBS or higher) from a recognized medical school.
1 year of clinical practice experience required.
0–1 years of experience in drug safety and pharmacovigilance preferred, within a pharmaceutical company, CRO, biotech, or regulatory agency.
Preferred Skills:
Good working knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
Experience with medical drug safety assessments, surveillance, and monitoring.
Proficiency in medical review of ICSRs, including SMQ coding, expectedness, causality assessments, narrative reviews, and benefit-risk assessments.
Experience interpreting safety data from clinical trials and post-marketing sources.
Strong relationship-building, collaboration, and influencing skills.
Excellent verbal, written, and presentation abilities.
Innovative, collaborative, and proactive mindset.
Compensation and Benefits:
Sitero offers a competitive salary, variable pay, paid time off, and comprehensive healthcare and retirement benefits.
Employment Type:
Permanent, Full-Time
Commitments:
Standard working hours: 40 hours per week, Monday to Friday, with a one-hour lunch break.
Willingness to work in shifts if required.
Disclaimer:
Sitero is an equal opportunity employer. All qualified applicants will be considered without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or other legally protected factors.
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