Pharmacovigilance Services Specialist
Location: Chennai, Tamil Nadu, India
Company: Accenture
Job Type: Full-Time
Job Category: Pharmacovigilance / Drug Safety
Experience Required: 7–11 Years
Job ID: AIOC-S01629624
Job Overview
Accenture is seeking an experienced Pharmacovigilance Services Specialist to support its Life Sciences and Healthcare operations in Chennai. This role focuses on ensuring the safety monitoring and regulatory compliance of pharmaceutical products by managing pharmacovigilance activities and delivering high-quality drug safety services to global clients.
The selected professional will work closely with client stakeholders, project leads, and cross-functional teams to manage pharmacovigilance projects, oversee safety data processing, and ensure adherence to global regulatory guidelines. The role requires strong analytical capabilities, pharmacovigilance expertise, and the ability to coordinate with multiple teams to ensure successful delivery of drug safety services.
Key Responsibilities
Pharmacovigilance Operations
Manage and oversee pharmacovigilance activities related to the detection, assessment, and reporting of adverse drug reactions.
Ensure accurate case identification, data entry, MedDRA coding, case processing, submission, and follow-up of Individual Case Safety Reports (ICSRs).
Maintain pharmacovigilance safety databases and ensure compliance with client guidelines and global regulatory standards.
Support drug safety surveillance activities by monitoring and analyzing safety data collected from clinical trials, healthcare professionals, and patients.
Project and Client Management
Collaborate with client project leads and service delivery teams to ensure timely and high-quality project delivery.
Manage project risks, issues, and escalations while ensuring compliance with agreed service levels.
Mobilize and coordinate resources required for pharmacovigilance service delivery.
Support continuous improvement initiatives to enhance operational efficiency and service quality.
Data Analysis and Risk Management
Analyze pharmacovigilance data to identify potential safety signals and emerging drug safety risks.
Contribute to risk management processes and safety monitoring activities.
Support regulatory reporting and compliance with international pharmacovigilance standards.
Team Collaboration and Leadership
Collaborate with cross-functional teams within Accenture and client organizations.
Manage small teams or workstreams when required, ensuring effective coordination and delivery of project objectives.
Provide guidance to team members on pharmacovigilance processes and regulatory requirements.
Required Qualifications
Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm).
Experience Required
7 to 11 years of experience in pharmacovigilance, drug safety, or clinical safety operations within the pharmaceutical, biotechnology, or life sciences industry.
Experience handling pharmacovigilance case processing, safety databases, and global regulatory reporting requirements.
Prior exposure to client-facing pharmacovigilance services or project delivery environments is preferred.
Key Skills
Pharmacovigilance and drug safety surveillance
ICSR case processing and MedDRA coding
Safety database management
Risk management and safety signal evaluation
Strong analytical and problem-solving skills
Effective written and verbal communication
Collaboration and stakeholder management
Work Environment
May require working in rotational shifts depending on project requirements.
Interaction with internal teams and client stakeholders across global locations.
About Accenture
Accenture is a leading global professional services company with strong capabilities in digital transformation, cloud services, and security. With more than 700,000 professionals serving clients in over 120 countries, Accenture delivers innovative solutions across industries including Life Sciences, Healthcare, Technology, and Financial Services.
Through its Life Sciences R&D services, Accenture supports pharmaceutical and biotechnology organizations in clinical development, pharmacovigilance, regulatory operations, and patient-centric solutions. By combining advanced technology with scientific expertise, the company helps organizations accelerate innovation and improve healthcare outcomes worldwide.
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