Role & Responsibilities
• Contribute to a culture of process improvement and operational excellence
• Review and process Serious Adverse Events (SAEs), spontaneous ADRs, and safety data
• Perform safety review of clinical and diagnostic data
• Ensure case processing accuracy as per SOPs, study procedures, regulatory and sponsor requirements
• Maintain and review safety tracking systems for data quality and compliance
• Liaise with investigational sites, reporters, sponsors, and cross-functional teams on safety issues
• Attend project team meetings and sponsor teleconferences as required
• Serve as a safety resource for investigational sites and internal teams
• Assist in training and mentoring junior Drug Safety Associates
• Support generation of study-specific procedures and identify out-of-scope activities
• Act as Lead Drug Safety Associate for local or regional projects
• Support MSS Functional Lead under supervision
• Travel up to 10% (domestic/international) as required
Qualification
• Life Sciences / Pharmacy / Healthcare background preferred
Experience
• 4–10 years of experience in Pharmacovigilance / Drug Safety
• Experience in Pharma, Biotech, CRO, or Clinical Research environments
Skills
• Strong knowledge of Pharmacovigilance processes
• Hands-on experience with Oracle Argus
• Knowledge of EudraVigilance and global safety databases
• Exposure to aggregate reporting activities
• Strong attention to detail and data quality focus
• Effective communication and stakeholder coordination skills
• Ability to work independently and lead safety activities
About the Company
• Covalent Trainings specialises in pharmacovigilance training and industry placements, Supports global PV projects across pharma, biotech, and CRO sectors
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