Pharmacovigilance Services Associate - Drug Safety Surveillance

Why This Role Matters
Ensuring patient safety is the cornerstone of modern healthcare, and pharmacovigilance plays a vital role in maintaining public trust in medications. As a Pharmacovigilance Services Associate at Accenture, you will be an integral part of monitoring, analyzing, and preventing adverse effects related to pharmaceutical products. By managing safety data and case reports, you help pharmaceutical companies meet regulatory requirements and make data-driven decisions to protect patients. Your work directly contributes to the assessment of drug safety and efficacy, enabling biopharma companies to deliver therapies that are both effective and safe. This role allows you to combine scientific knowledge, regulatory understanding, and analytical skills to make a tangible impact on patient health worldwide.

Job Description
The Pharmacovigilance Services Associate will be part of Accenture’s Life Sciences R&D vertical, within the Clinical, Pharmacovigilance & Regulatory sub-offering. The position focuses on end-to-end drug safety surveillance, ensuring that adverse event data from clinical trials, healthcare providers, and patients is accurately captured, processed, and analyzed in accordance with global regulatory standards. In this role, you will manage Individual Case Safety Reports (ICSRs) in safety databases, including case identification, data entry, MedDRA coding, case processing, submission, and follow-ups as per client guidelines. Employees will use specialized pharmacovigilance systems and workflows to ensure that safety data is complete, reliable, and available for regulatory reporting. The role is crucial for supporting timely safety assessments, detecting trends, and mitigating risks associated with pharmaceutical products.
By joining Accenture, you will gain exposure to global regulatory standards, cross-functional safety operations, and advanced pharmacovigilance processes, contributing to both patient safety and organizational compliance.

Key Features of the Role: Responsibilities
• Solve routine problems primarily through precedent and general guidelines.
• Perform daily tasks under detailed to moderate instructions and handle new assignments with provided guidance.
• Manage ICSRs in the safety database including case identification, data entry, MedDRA coding, processing, submission, and follow-ups.
• Ensure accuracy and completeness of safety data in compliance with client and global regulatory requirements.
• Collaborate within your team and with your direct supervisor to resolve queries, discrepancies, or workflow issues.
• Maintain documentation for case processing activities and adhere to standard operating procedures (SOPs).
• Contribute to continuous process improvement initiatives within pharmacovigilance operations.
• Act as an individual contributor with a focused scope of work, while supporting team objectives.
• Adapt to rotational shift schedules as required to maintain uninterrupted safety monitoring.
• Engage in ongoing learning and skill development to stay current with regulatory updates, MedDRA coding standards, and pharmacovigilance best practices.

Required Qualifications
• Bachelor of Pharmacy (BPharm), Bachelor in Physiotherapy (BPT), or BSc Nursing.
• 1 to 3 years of experience in pharmacovigilance, drug safety, or clinical research.
• Familiarity with pharmacovigilance databases, safety reporting, and regulatory compliance is preferred.
• Strong attention to detail, analytical thinking, and problem-solving abilities.
• Adaptable and flexible with the ability to learn quickly and work collaboratively in a team environment.
• Effective communication skills to interact with peers, supervisors, and other stakeholders.

Educational Requirements
• Bachelor’s degree in Pharmacy, Physiotherapy, Nursing, or a related discipline.
• Understanding of clinical trial safety processes, ICSR reporting, and regulatory requirements.
• Knowledge of MedDRA coding and pharmacovigilance standards is advantageous.

Experience and Skills
• 1 to 3 years of professional experience in pharmacovigilance, clinical safety, or related healthcare operations.
• Proficiency with pharmacovigilance systems, case processing workflows, and safety databases.
• Ability to accurately manage, code, and track adverse event data.
• Strong organizational skills to handle multiple cases while maintaining data quality.
• Problem-solving skills to identify issues, implement solutions, and escalate when necessary.
• Team-oriented mindset, with the ability to work under supervision and follow detailed instructions.

Salary Insights
• Competitive salary commensurate with experience and market benchmarks.
• Benefits may include health coverage, professional development programs, and performance-based incentives.

Company Overview
Accenture is a global professional services company with capabilities in digital, cloud, and security. With over 784,000 employees across more than 120 countries, Accenture helps organizations leverage technology and human ingenuity to drive value and innovation. The Life Sciences R&D vertical focuses on supporting biopharma companies through clinical trials, regulatory affairs, pharmacovigilance, and patient services. Accenture fosters a collaborative, learning-driven environment where employees can contribute to global healthcare improvements while developing their own expertise in safety and regulatory compliance.

FAQs
• What is the main focus of this role?
Monitoring, managing, and analyzing adverse events to ensure drug safety and regulatory compliance.

• Which systems or tools will I use?
Pharmacovigilance safety databases, MedDRA coding tools, and case processing platforms.

• Will I interact with clients?
Interactions are primarily within your team and supervisor, though processed data supports client reporting and regulatory submissions.

Application Tips
• Highlight your experience in pharmacovigilance, safety data management, and ICSR handling.
• Emphasize your attention to detail, adaptability, and problem-solving skills.
• Showcase knowledge of MedDRA coding and regulatory requirements.
• Tailor your resume to reflect contributions to safety case management, data quality, and compliance adherence.