Safety Science Specialist – Pharmacovigilance (Bangalore, India)
Location: Bangalore, Karnataka, India
Job Category: Clinical / Pharmacovigilance
Experience Required: 3–5 years in pharmacovigilance with clinical trial case processing experience
Job ID: 255848
About the Role
We are seeking a Safety Science Specialist to manage and support clinical safety operations for pharmaceutical and biotechnology products. The role involves processing and managing adverse events (AEs/SAEs) from clinical trials and post-marketing sources, ensuring timely reporting to regulatory authorities, clients, and internal stakeholders. This role contributes to maintaining high-quality pharmacovigilance standards while supporting compliance with global regulations and internal SOPs.
Key Responsibilities
Manage receipt, review, and processing of all adverse event reports, both spontaneous and solicited from clinical trials.
Perform data entry of safety data into AE databases and tracking systems with high accuracy.
Write patient narratives and code adverse events accurately using MedDRA.
Determine case listedness against approved product labels (where applicable).
Identify missing clinically significant information and coordinate follow-ups with medical staff.
Ensure timely medical review and expedite reporting of serious adverse events (SAEs) to regulatory agencies, ethics committees, investigators, clients, and third-party vendors.
Assist with database reconciliation and maintenance of adverse event tracking systems.
Manage processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) according to study timelines.
Maintain and organize project files, central safety files, and study documentation.
Conduct quality and peer reviews of safety reports; track trends and recommend corrective actions.
Support preparation for audits, inspections, and client meetings, including documentation for safety committees or DSMBs.
Contribute to root cause analysis and CAPA development for quality issues.
Demonstrate adherence to SOPs, WIs, and regulatory guidance in all pharmacovigilance activities.
Provide training and mentoring to junior staff as required.
Qualifications and Experience Required
3–5 years of experience in pharmacovigilance (PV); clinical trial case processing experience is mandatory.
For PharmD candidates, one-year residency or fellowship may be considered relevant experience.
Bachelor’s or Master’s degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field.
Strong knowledge and hands-on experience in AE/SAE processing, narrative writing, queries, safety databases, and regulatory submissions.
Familiarity with global pharmacovigilance regulations and industry best practices.
Relevant experience in pharmaceuticals, biotechnology, or CROs, including exposure to Medical Affairs, Clinical Data Management, Clinical Monitoring, Regulatory Affairs, or Quality Assurance.
Skills and Competencies
High degree of accuracy and attention to detail.
Strong team player with excellent written and verbal communication skills.
Ability to work independently and prioritize tasks effectively.
Proficient in MS Office and Windows applications; good keyboard skills.
Presentation, training, and mentoring skills are advantageous.
Why Join Us?
Work in a dynamic, global pharmacovigilance environment impacting patient safety worldwide.
Collaborate with cross-functional teams in clinical, regulatory, and safety operations.
Opportunity to develop expertise in clinical trial safety management and pharmacovigilance operations.
Location: Bangalore, India
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