Senior Pharmacovigilance Scientist
Location: Bengaluru, Karnataka, India
Work Mode: Hybrid
Job Type: Full-Time
Experience Required: 6–10+ years
Industry: Pharmacovigilance | Drug Safety | Clinical Research
Job Overview
Quanticate, a leading global data-focused Contract Research Organization (CRO), is seeking an experienced Senior Pharmacovigilance Scientist to lead end-to-end pharmacovigilance delivery across clinical development and post-marketing programs. This is a hands-on, client-facing role with responsibility for managing complex safety operations, regulatory safety reporting, and safety surveillance activities.
The successful candidate will play a critical leadership role in ensuring regulatory compliance, supporting audits and inspections, mentoring junior staff, and continuously improving pharmacovigilance processes across global projects.
Key Responsibilities
Manage the end-to-end lifecycle of Individual Case Safety Reports (ICSRs) from clinical trials, spontaneous sources, and literature.
Review safety cases for data quality, completeness, seriousness, expectedness, privacy, and regulatory timelines.
Prepare high-quality case narratives, manage follow-ups, and ensure appropriate medical review.
Enter, maintain, and quality-check safety data within validated pharmacovigilance databases.
Prepare and submit expedited safety reports to global health authorities in compliance with regulatory requirements.
Act as the Pharmacovigilance Lead for assigned projects and serve as the primary client contact for safety operations.
Develop and maintain study-specific Safety Management Plans and local reporting documentation.
Perform safety data reconciliation with clinical data management teams and ensure compliance with data exchange agreements.
Support signal detection activities, literature monitoring, and preparation of aggregate safety reports such as DSURs and PSURs.
Track project metrics, support budget oversight, and assist with invoicing activities.
Contribute to SOP development and ensure audit and inspection readiness.
Mentor, train, and provide operational guidance to junior pharmacovigilance staff.
Support business development initiatives, including proposal development and bid defense activities, as required.
Experience & Skills Required
Experience: Minimum 6–10+ years of hands-on experience in pharmacovigilance operations across clinical trials and post-marketing safety.
Strong expertise in ICSR processing, quality review, and regulatory safety submissions.
Practical experience with Oracle Argus (mandatory); familiarity with ABCube, SafetyEasy, and EudraVigilance preferred.
Proven experience leading pharmacovigilance activities on client-facing projects.
Solid understanding of global pharmacovigilance regulations and guidelines.
Experience supporting SOP development, audits, and regulatory inspections.
Strong knowledge of medical and scientific terminology.
Excellent written and verbal communication skills.
High attention to detail with a strong commitment to quality, compliance, and timelines.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Why Join Quanticate
Work with a world-leading data-focused CRO supporting complex global clinical programs.
Exposure to both large pharmaceutical companies and emerging biotech organizations.
Strong emphasis on career development, mentoring, and professional society engagement.
Opportunity to work on high-impact clinical programs that contribute to meaningful patient outcomes.
Compensation & Benefits
Competitive salary, open to discussion based on experience.
Flexible and hybrid working model.
Comprehensive leave policy including annual, sick, casual, and public holidays.
Medical insurance coverage for self and immediate family.
Gratuity and accidental insurance coverage.
Access to continuous learning and development programs, including mentoring, coaching, e-learning, and job shadowing.
About Quanticate
Quanticate is a globally recognized Contract Research Organization specializing in biostatistics, statistical programming, data management, and pharmacovigilance. The company partners with leading pharmaceutical organizations and innovative biotech companies to deliver high-quality data-driven solutions across the clinical development lifecycle.
Equal Opportunity & Recruitment Disclaimer
Quanticate is an equal opportunity employer. All employment decisions are based on merit, qualifications, and business needs. Quanticate does not charge any fees at any stage of the recruitment process. All official communication will originate from a verified @quanticate.com email address.
SEO & Portal Optimization Keywords
Senior Pharmacovigilance Scientist jobs in Bengaluru, Drug Safety jobs India, Pharmacovigilance CRO careers, Oracle Argus jobs, Clinical and Post-Marketing Safety roles, Hybrid Pharmacovigilance jobs.
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