Pharmacovigilance Services Senior Manager
Job ID: AIOC-S01623460
Employment Type: Full-Time
Location: Bengaluru, India
Experience Required: 12–15+ Years
Function: Pharmacovigilance Operations | Drug Safety Surveillance
Industry: Life Sciences | Pharmaceutical | Healthcare Consulting
Job Overview
Accenture is seeking an experienced Pharmacovigilance Services Senior Manager to lead large-scale pharmacovigilance and drug safety operations for global life sciences clients. This leadership role is responsible for ensuring compliant, efficient, and high-quality delivery of end-to-end pharmacovigilance services, including individual case safety reporting, aggregate reporting, and safety surveillance.
The role involves strategic oversight, client engagement, people management, and continuous improvement to strengthen patient safety outcomes and operational excellence.
Key Responsibilities
Strategic & Client Leadership
Lead Accenture’s pharmacovigilance service delivery for assigned clients, ensuring alignment with contractual, regulatory, and business expectations
Act as senior escalation point for client risks, issues, and operational challenges
Partner with client leadership and internal stakeholders to drive service excellence and long-term value
Pharmacovigilance Operations Oversight
Oversee end-to-end Individual Case Safety Report (ICSR) processing, ensuring timely and accurate submissions to global regulatory authorities
Maintain project oversight for aggregate safety reports, including PSURs, DSURs, and other regulatory deliverables
Provide leadership in safety signal detection, evaluation, and management activities
Ensure full compliance with global pharmacovigilance regulations (ICH, FDA, EMA, and other regional requirements)
People & Resource Management
Lead and manage Team Leads and Tower Leads, ensuring achievement of individual and group performance targets
Drive workforce planning, recruitment, onboarding, and capacity management in collaboration with HR
Monitor team morale, performance, promotions, compensation, and employee relations
Provide mentorship, coaching, and career development guidance to senior and mid-level leaders
Quality, Compliance & Risk Management
Ensure adherence to internal SOPs, quality standards, and regulatory expectations
Implement and monitor quality management systems to ensure data integrity, accuracy, and audit readiness
Lead CAPA initiatives arising from audits, inspections, or performance metrics
Review MIS and operational dashboards to identify risks and implement corrective actions
Financial & Operational Governance
Manage budgets, forecasting, and financial performance for pharmacovigilance operations
Optimize resource deployment to ensure efficiency, scalability, and cost-effectiveness
Collaborate with enabling teams to ensure infrastructure, systems, and tools availability
Process Improvement & Innovation
Identify opportunities for automation, standardization, and process optimization
Lead continuous improvement initiatives to enhance productivity, compliance, and scalability
Contribute to business and industry strategy development within pharmacovigilance services
Required Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline
Minimum 12 years of experience in pharmacovigilance or drug safety, with senior leadership exposure
Strong expertise in ICSR management, aggregate reporting, and safety surveillance
In-depth knowledge of global pharmacovigilance regulations and guidelines (ICH, FDA, EMA)
Proven experience managing large, multi-level teams and complex client engagements
Hands-on experience with safety databases such as Argus, ARISg, or equivalent systems
Excellent analytical, problem-solving, and decision-making skills
Strong verbal and written communication skills in English
Demonstrated ability to lead cross-functional teams in a global delivery model
Preferred Qualifications
Advanced degree such as PharmD or PhD
Experience in consulting-led or outsourced pharmacovigilance delivery models
Exposure to digital transformation, automation, or AI-driven safety operations
Strong background in budgeting, forecasting, and contract governance
About Accenture
Accenture is a global professional services company with capabilities across digital, cloud, security, and life sciences operations. With more than 780,000 professionals serving clients in over 120 countries, Accenture combines deep industry expertise with advanced technology to drive meaningful outcomes and innovation.
Why This Role Matters
This position plays a critical role in safeguarding patient safety while enabling scalable, compliant, and future-ready pharmacovigilance operations for global pharmaceutical clients. It offers the opportunity to influence strategy, lead transformation, and operate at the highest level of drug safety leadership.
Gujarat :
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Siliguri |Illinois :
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