Pharmacovigilance Services Specialist Drug Safety Surveillance

Why This Role Matters

The Pharmacovigilance Services Specialist plays a critical role in ensuring patient safety through effective drug safety surveillance and regulatory compliance. This position oversees pharmacovigilance service delivery, ensuring high-quality case processing, risk management, and regulatory reporting aligned with global standards.
By managing operational teams, mitigating risks, and ensuring timely submission of Individual Case Safety Reports (ICSRs), the role directly contributes to maintaining public trust in medicines and ensuring compliance with international pharmacovigilance regulations.

Job Description

Accenture is hiring a Pharmacovigilance Services Specialist to oversee service delivery in drug safety surveillance operations. The selected candidate will manage pharmacovigilance case processing activities, coordinate with client project leads, oversee team performance, and ensure compliance with global regulatory requirements. The role may involve rotational shifts and interaction with internal and client stakeholders.

Key Features of the Role

• Position: Pharmacovigilance Services Specialist
• Skill Area: Pharmacovigilance & Drug Safety Surveillance
• Experience Required: 7–11 years
• Qualification: B.Pharm / M.Pharm
• Industry: Pharmacovigilance / Life Sciences Operations
• Work Requirement: May require rotational shifts

Key Responsibilities

Service Delivery & Team Management
• Oversee end-to-end pharmacovigilance service delivery
• Mobilize and manage resources to meet client requirements
• Monitor team performance and ensure high-quality outputs
• Manage risks, issues, and escalations with client and internal stakeholders

Case Processing & Drug Safety Operations
• Manage case identification, data entry, and MedDRA coding
• Oversee case processing, submissions, and follow-ups for ICSRs
• Ensure compliance with global regulatory requirements and client guidelines
• Maintain data accuracy in safety databases

Risk & Compliance Oversight
• Support detection, assessment, and prevention of adverse drug effects
• Ensure adherence to pharmacovigilance regulatory standards
• Drive quality improvements and process optimization
• Support compliance audits and regulatory inspections

Problem Solving & Decision Making
• Analyze and resolve moderately complex issues
• Adapt existing methods to create improved solutions
• Make decisions that impact team operations and service quality
• Align team activities with strategic goals set by senior management

Required Qualifications

Educational Background:
• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

Experience:
• 7–11 years of experience in Pharmacovigilance / Drug Safety
• Strong experience in ICSR case processing and regulatory submissions
• Experience managing small teams or leading workstreams

Core Skills:
• Strong analytical and problem-solving skills
• Excellent written and verbal communication
• Risk management and issue resolution capability
• Collaboration and stakeholder management skills
• Understanding of global pharmacovigilance regulations

Soft Skills:
• Leadership and team coordination
• Ability to work under deadlines
• Client-facing communication skills
• Adaptability in a dynamic environment

Company Overview

Accenture is a global professional services organization with expertise in digital, cloud, security, strategy, consulting, technology, and operations. With over 784,000 employees serving clients in more than 120 countries, Accenture combines technology and human ingenuity to drive business transformation across industries. In the life sciences sector, Accenture supports pharmacovigilance services that ensure regulatory compliance, operational excellence, and patient safety.

FAQs

Q1. Is team management experience required?
Yes, candidates should have experience managing small teams or workstreams.

Q2. Is hands-on case processing experience necessary?
Yes, strong exposure to ICSR case processing and MedDRA coding is required.

Q3. Does the role involve client interaction?
Yes, collaboration with client project leads and internal stakeholders is a key component.

Q4. Are rotational shifts mandatory?
Yes, this role may require working in rotational shifts.

Q5. What experience level is expected?
Candidates must have 7–11 years of pharmacovigilance experience.

Application Tip

• Highlight experience in ICSR case management and MedDRA coding
• Showcase leadership or team management exposure
• Mention regulatory submission and compliance experience
• Demonstrate risk management and escalation handling examples
• Include client-facing project coordination experience