Medical Reviewer - Trainee
Location: Mysore (Hybrid)
Function: Drug Safety **Employment **
Type: Permanent, Full Time
About Sitero: Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. We provide innovative, technology-enabled solutions for early-phase to Phase III clinical trials, ensuring safety, ethics, compliance, and innovation.
Job Description: The Medical Reviewer - Trainee will be a key contact for assigned clinical development or marketed products. Responsibilities include safety strategy, major safety deliverables, and cross-functional benefit-risk profile assessments. The role requires strong medical knowledge, drug safety expertise, and collaboration with internal and external stakeholders.
Essential Duties and Responsibilities:
Analyze, review, and interpret non-clinical and clinical safety data.
Perform medical review of ICSRs and drug safety information from various sources (clinical trials, spontaneous/solicited reports, literature, etc.).
Assess causality of ICSRs and identify process improvement opportunities.
Contribute to aggregate safety reports (DSURs, PBRERs) and ensure regulatory compliance.
Develop and update SOPs, Working Instructions, and other guidance documents.
Provide safety and pharmacovigilance training to internal teams and at investigator meetings.
Collaborate with Regulatory Affairs for pharmacovigilance reporting to regulatory agencies and prescribers.
Act as a subject matter expert for pharmacovigilance service vendors.
Train and mentor Pharmacovigilance Physicians and Specialists.
Ensure compliance with global PV regulations and guidelines (CIOMS, FDA, EMA, ICH, etc.).
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 within pharmaceutical/biotech companies, CROs, or regulatory agencies (preferred).
Preferred Skills:
Knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines.
Experience with medical drug safety assessments and surveillance activities.
Proficiency in ICSR medical reviews (SMQs, expectedness/causality assessments, narrative reviews, etc.).
Ability to interpret safety data from clinical trials and post-marketing sources.
Strong relationship-building and cross-disciplinary collaboration skills.
Excellent verbal, written, and presentation skills.
Innovative, collaborative, and proactive mindset.
Compensation & Benefits:
Competitive salary with variable pay.
Paid time off.
Healthcare and retirement benefits.
Commitments:
Standard hours: 40 hours per week (Monday-Friday) with one hour lunch break.
Additional hours as needed.
Willingness to work in shifts as required.
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