APCER Life Sciences Hiring For Pharmacovigilance Associate

Responsibilities

• Receive, acknowledge, and log incoming Individual Case Safety Reports (ICSRs) from healthcare professionals, patients, and literature sources.
• Perform initial data entry of ICSR information into the safety database (e.g., Argus, Arisg, or VigiBase) ensuring accuracy and completeness.
• Conduct source document verification and medical coding of adverse events using MedDRA terminology.
• Assess causality, seriousness, and expectedness of reported adverse events according to regulatory guidelines.
• Prepare and submit expedited safety reports (e.g., SUSAR, DSUR) to regulatory authorities within stipulated timelines.
• Generate periodic safety aggregate reports such as Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR).
• Perform signal detection activities by reviewing aggregated safety data for emerging trends.
• Liaise with internal clinical, medical affairs, and regulatory teams to obtain missing information for case completion.
• Ensure compliance with global pharmacovigilance regulations (e.g., FDA, EMA, CDSCO) and company SOPs.
• Conduct literature screening and data extraction for safety information from scientific publications.
• Participate in safety data reconciliation and data quality audits.
• Support the preparation of risk management plans (RMP) and risk minimization activities.
• Contribute to the development and maintenance of pharmacovigilance SOPs and work instructions.
• Provide training and mentorship to junior PV associates and interns.
• Assist in the preparation of safety sections for clinical trial protocols and investigator brochures.
• Review and validate safety data in clinical trial safety databases (eCRF) for accuracy.
• Manage and track safety queries and follow‑up actions in the safety database.
• Perform batch record review for biologics and ensure product safety documentation.
• Support pharmacovigilance inspections and respond to regulatory queries.
• Conduct post‑marketing surveillance activities including product complaint handling.
• Maintain up‑to‑date knowledge of evolving pharmacovigilance regulations and industry best practices.
• Generate ad‑hoc safety analyses and data extracts for cross‑functional projects.
• Participate in cross‑functional safety review meetings and present case summaries.
• Ensure timely transmission of safety information to marketing authorization holders (MAHs) and partners.
• Review and approve safety‑related labeling changes and package inserts.
• Coordinate with external vendors for safety database management and data entry services.
• Document all activities in the safety database audit trail according to GCP standards.
• Support the preparation of safety presentations for internal and external stakeholders.
• Conduct root‑cause analysis of safety data discrepancies and implement corrective actions.
• Contribute to continuous improvement initiatives within the pharmacovigilance department.

Skills

• MedDRA coding
• WHO-ART familiarity
• Argus safety database proficiency
• ICH E2B(R3) guidelines
• FDA 21 CFR Part 314
• EMA GVP modules
• CDSCO pharmacovigilance rules
• Causality assessment (WHO-UMC, Naranjo)
• Seriousness criteria evaluation
• Signal detection techniques
• Literature review and data extraction
• Clinical trial safety data management
• Risk Management Plan development
• DSUR and PSUR preparation
• Excellent medical writing skills
• Attention to detail and data accuracy
• Strong analytical and problem‑solving abilities
• Effective communication with cross‑functional teams
• Time‑management and ability to meet strict deadlines
• Knowledge of GCP and GVP compliance
• Proficiency in Microsoft Office (Excel, PowerPoint)
• Ability to work with cross‑functional stakeholders
• Understanding of pharmacology and drug safety concepts
• Experience with electronic safety reporting tools
• Ability to handle multiple concurrent cases
• Knowledge of regulatory submission timelines
• Critical thinking for root‑cause analysis
• Training and mentorship capabilities
• Familiarity with batch record review processes
• Adaptability to evolving regulatory environments

Company Overview

APCERLS (Advanced Pharmacovigilance and Clinical Research Services Ltd.) is a leading Indian drug‑safety and clinical research organization that specializes in comprehensive pharmacovigilance solutions for multinational pharmaceutical companies and domestic manufacturers. With a robust portfolio covering safety data management, signal detection, risk management planning, and regulatory reporting, APCERLS serves a diverse therapeutic spectrum including oncology, cardiovascular, and rare diseases. The company operates state‑of‑the‑art safety centers in Noida and Ahmedabad, leveraging cutting‑edge safety databases such as Argus and VigiBase to deliver real‑time adverse event monitoring. APCERLS is recognized for its strong market presence, ISO‑9001 certification, and a track record of successful regulatory inspections across FDA, EMA, and CDSCO jurisdictions. Employees benefit from structured career growth pathways, continuous learning programs, mentorship from seasoned safety experts, and exposure to global clinical trials, making APCERLS an ideal platform for aspiring pharmacovigilance professionals seeking industry‑leading experience and advancement.

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