Pharmacovigilance Associate - Drug Safety Surveillance & Case Processing

Why This Role Matters
Pharmacovigilance is a critical function in the healthcare and pharmaceutical industry, ensuring that medicines remain safe and effective throughout their lifecycle. Monitoring adverse events and drug safety data helps identify potential risks early and enables organizations to take preventive actions that protect patient health. As a Pharmacovigilance Services Associate at Accenture, you will contribute to global drug safety surveillance by supporting the detection, assessment, and prevention of adverse effects associated with pharmaceutical products.
Your work will directly support pharmaceutical companies and healthcare organizations in maintaining regulatory compliance and ensuring that safety data is captured accurately and reported in a timely manner. By managing and processing Individual Case Safety Reports, you help maintain the integrity of drug safety information that informs healthcare decisions worldwide. This role allows you to apply your healthcare background in a structured, analytical environment while gaining exposure to international pharmacovigilance practices and regulatory frameworks.

Job Description
The Pharmacovigilance Services Associate will work within Accenture’s Life Sciences R&D vertical, specifically in the Clinical, Pharmacovigilance & Regulatory sub-offering. This role focuses on supporting drug safety surveillance operations for global pharmaceutical clients by ensuring accurate processing and management of safety information. Employees in this position will be responsible for handling pharmacovigilance case processing activities such as case identification, safety data entry, MedDRA coding, case processing, submission, and follow-up activities for Individual Case Safety Reports. All tasks must be performed according to client guidelines, global regulatory requirements, and internal standard operating procedures. The role requires strong attention to detail and the ability to follow structured processes while maintaining data quality and regulatory compliance. Employees will work closely with their own team and direct supervisors to resolve routine issues, clarify instructions, and ensure accurate completion of assigned tasks. This is an individual contributor role where employees perform specific operational tasks within a defined scope of work while contributing to overall pharmacovigilance operations. The role may also involve working in rotational shifts to support global clients and maintain continuous drug safety monitoring activities.

Key Features of the Role: Responsibilities
• Perform case identification and intake of adverse event reports from multiple sources.
• Enter safety information accurately into pharmacovigilance safety databases.
• Perform MedDRA coding for adverse events, indications, and medical history.
• Process Individual Case Safety Reports according to regulatory guidelines and client procedures.
• Conduct follow-up activities to obtain missing case information and ensure data completeness.
• Maintain high standards of accuracy and quality while handling safety data.
• Work collaboratively with team members and supervisors to resolve routine issues.
• Follow established pharmacovigilance processes and standard operating procedures.
• Contribute to maintaining compliance with global drug safety reporting requirements.
• Participate in internal training programs to strengthen knowledge of pharmacovigilance systems and regulatory standards.

Required Qualifications
• Bachelor of Pharmacy, Bachelor in Physiotherapy, or BSc Nursing.
• 1 to 3 years of experience in pharmacovigilance, clinical safety, or healthcare operations.
• Basic knowledge of pharmacovigilance case processing and drug safety monitoring.
• Strong attention to detail and ability to manage safety data accurately.
• Ability to work effectively within a team environment.
• Adaptable and flexible with strong willingness to learn new systems and processes.

Educational Requirements
• Bachelor’s degree in Pharmacy, Physiotherapy, Nursing, or a related healthcare discipline.
• Basic understanding of pharmacovigilance workflows and adverse event reporting processes.
• Familiarity with MedDRA terminology and safety databases is beneficial.

Experience and Skills
• 1 to 3 years of experience in pharmacovigilance operations or clinical safety roles.
• Understanding of Individual Case Safety Report processing and safety data management.
• Strong analytical and problem-solving abilities.
• Good communication skills to interact with team members and supervisors.
• Ability to follow detailed instructions and maintain high-quality standards in safety reporting tasks.

Salary Insights
• Competitive salary based on experience and industry benchmarks.
• Additional benefits may include health insurance, learning and development programs, and performance-based incentives.

Company Overview
Accenture is a global professional services company with expertise in digital transformation, cloud technology, and business operations. With over 784,000 employees serving clients in more than 120 countries, Accenture helps organizations drive innovation and operational excellence through technology and human ingenuity. Within the Life Sciences R&D vertical, Accenture provides services across clinical trials, pharmacovigilance, regulatory compliance, and patient services. These solutions help pharmaceutical and biotechnology companies accelerate research, ensure regulatory compliance, and deliver safe and effective treatments to patients worldwide. Accenture’s collaborative and learning-focused work environment allows employees to build expertise while contributing to advancements in global healthcare.

FAQs
• What is the main focus of this role?
The role focuses on managing pharmacovigilance case processing activities and monitoring adverse event reports to ensure drug safety.

• Will I work with pharmacovigilance databases?
Yes, the role involves working with safety databases to process Individual Case Safety Reports and manage safety information.

• Is teamwork important for this role?
Yes, employees collaborate with their team and supervisors to ensure accuracy and compliance in safety reporting processes.

Application Tips
• Highlight any experience related to pharmacovigilance, clinical safety, or adverse event reporting.
• Mention knowledge of MedDRA coding and pharmacovigilance databases if applicable.
• Emphasize your attention to detail, teamwork skills, and adaptability.
• Tailor your resume to demonstrate your understanding of drug safety surveillance and regulatory compliance.