Pharmacovigilance Services Associate Manager

Role Overview

Accenture Solutions Pvt Ltd is seeking an experienced Pharmacovigilance Services Associate Manager to join its life sciences practice in Chennai. In this role, you will lead and oversee pharmacovigilance (PV) operations, ensuring compliance with global drug safety regulations and guidelines. You will manage cross-functional teams, drive process excellence, and serve as a subject matter expert to deliver high-quality safety services for pharmaceutical and biotech clients.

Key Responsibilities

Lead end-to-end pharmacovigilance operations including adverse event processing, case management, and regulatory reporting
Manage and mentor a team of PV professionals, ensuring timely and accurate delivery of safety services
Oversee Individual Case Safety Report (ICSR) processing and submission in compliance with ICH, EMA, FDA, and other regulatory guidelines
Ensure adherence to SOPs, work instructions, and client-specific requirements for drug safety activities
Coordinate with clients, regulatory authorities, and internal stakeholders to resolve safety-related queries and issues
Monitor key performance indicators (KPIs) and service level agreements (SLAs) to maintain operational excellence
Drive process improvement initiatives and implement best practices within the PV function
Support audits, inspections, and quality reviews related to pharmacovigilance activities
Contribute to business development efforts including proposal writing and client presentations
Collaborate with medical, clinical, and regulatory affairs teams to support signal detection and risk management activities

Requirements / Qualifications

Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, or a related field
Extensive experience in pharmacovigilance or drug safety within the pharmaceutical, biotech, or CRO/BPO sector
Strong knowledge of global PV regulations and guidelines (ICH E2A–E2F, EudraVigilance, FDA MedWatch, WHO VigiBase)
Proven experience in managing teams and overseeing large-scale PV operations
Proficiency in safety databases such as Argus Safety, ARISg, or Oracle Empirica
Excellent understanding of ICSR lifecycle, aggregate reporting, and signal management
Strong analytical, problem-solving, and decision-making skills
Effective communication and stakeholder management abilities
Experience with process improvement methodologies (e.g., Lean, Six Sigma) is an advantage
Ability to work in a dynamic, client-facing environment with shifting priorities

About the Company

Accenture Solutions Pvt Ltd is the India-based subsidiary of Accenture, a global professional services company specializing in digital transformation, technology, consulting, and outsourcing solutions across industries including life sciences, healthcare, finance, and more. The company delivers innovative services and solutions that help clients improve performance and create sustainable value across their organizations.