Job Title: Pharmacovigilance Services Specialist
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Experience Required: 7–11 Years
Function: Pharmacovigilance Operations | Drug Safety & Surveillance
Job ID: AIOC-S01621675
Company: Accenture
Accenture is hiring an experienced Pharmacovigilance Services Specialist to support and strengthen Pharmacovigilance (PV) Operations and Drug Safety Surveillance programs. This role is critical in ensuring quality, compliance, and regulatory adherence across global pharmacovigilance engagements while supporting audits, inspections, and continuous process improvements.
The position is ideal for professionals with strong experience in PV quality assurance, compliance oversight, and regulatory frameworks, who can work in complex, multi-stakeholder environments.
Oversee and ensure adherence to the Quality Management Framework for pharmacovigilance engagements
Implement and maintain Quality Assurance (QA) programs across PV projects
Establish quality and compliance processes during transition of new PV deals
Provide compliance oversight for assigned pharmacovigilance projects
Support client audits, due diligence activities, and regulatory inspections
Act as the primary point of contact for audits, inspection readiness, and follow-up activities
Develop, review, and maintain SOPs and quality documentation for assigned projects
Monitor deviations and support development, implementation, and closure of CAPAs
Ensure data privacy, confidentiality, and security measures are implemented across delivery teams
Participate in governance meetings and present quality and compliance updates
Track contract updates and ensure timely incorporation of process changes
Drive process standardization across global locations for assigned PV projects
Ensure compliance with global regulatory requirements including ICH, GCP, FDA, MHRA, and client-specific guidelines
Serve as a subject matter expert for regulatory training and quality-related queries
Coordinate regulatory audits across multiple engagements
Develop Quality Management Plans for PV deals as per contractual and regulatory requirements
Perform additional quality and compliance responsibilities as assigned by management
Education
Bachelor’s degree in Life Sciences, Pharmacy, or Medicine
Acceptable qualifications include BAMS, Bachelor’s or Master’s degree in Life Sciences
Experience
7 to 11 years of relevant experience in Pharmacovigilance, Drug Safety, or PV Quality Assurance
Prior experience in QA or auditing within Pharmacovigilance, Clinical Operations, Medical Writing, or related pharma domains is strongly preferred
Strong understanding of Pharmacovigilance regulations and global quality standards
Working knowledge of ICH, GCP, FDA, MHRA, and other global regulatory requirements
Excellent attention to detail with the ability to report facts accurately
Strong verbal and written communication skills
Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
Strong interpersonal skills with the ability to collaborate across teams and stakeholders
Ability to manage multiple priorities in a regulated, deadline-driven environment
Accenture is a leading global professional services company with capabilities in digital, cloud, and security. With deep industry expertise across more than 40 industries, Accenture delivers Strategy & Consulting, Technology, Operations, and Accenture Song services. With a global workforce of over 780,000 professionals across 120+ countries, Accenture helps clients drive innovation, efficiency, and sustainable growth through technology and human ingenuity.
Work on global pharmacovigilance and drug safety programs
Be part of a high-impact, regulatory-driven environment
Gain exposure to international clients, audits, and inspections
Continuous learning, career growth, and leadership opportunities
Inclusive culture focused on innovation, quality, and compliance excellence
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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