Pharmacovigilance Associate - Drug Safety & Case Processing

Why This Role Matters
Patient safety is one of the most critical priorities in healthcare and pharmaceutical development. Pharmacovigilance plays a vital role in ensuring that medicines available in the market remain safe, effective, and continuously monitored throughout their lifecycle. As a Pharmacovigilance Services Associate at Accenture, you will contribute to global drug safety surveillance by identifying, documenting, and managing adverse event reports related to pharmaceutical products. Your work will help pharmaceutical companies and regulatory authorities identify potential risks, evaluate safety signals, and ensure compliance with international safety standards. By maintaining high-quality safety data and supporting pharmacovigilance processes, you help protect patient health and strengthen trust in medical treatments. This role offers an opportunity to apply clinical and scientific knowledge while working with advanced safety databases and global regulatory frameworks.

Job Description
The Pharmacovigilance Services Associate will be part of Accenture’s Life Sciences Research and Development vertical, within the Clinical, Pharmacovigilance & Regulatory sub-offering. This role focuses on monitoring and managing safety information related to pharmaceutical products. Employees in this role are responsible for processing Individual Case Safety Reports (ICSRs) by collecting safety information, verifying case details, coding medical terms using MedDRA, and entering the information into pharmacovigilance databases. The role also includes case follow-up, documentation, and submission in accordance with global regulatory requirements and client guidelines. You will work closely with your team members and supervisors to ensure that all safety cases are processed accurately and within defined timelines. The position requires strict adherence to standard operating procedures, regulatory guidelines, and quality standards. The work environment emphasizes teamwork, structured processes, and continuous learning, allowing employees to develop expertise in drug safety surveillance and regulatory compliance. This role may also require working in rotational shifts to support global pharmacovigilance operations and ensure continuous safety monitoring for pharmaceutical clients worldwide.

Key Features of the Role: Responsibilities
• Perform case identification and intake of adverse event reports from multiple sources.
• Enter safety data into pharmacovigilance databases with accuracy and completeness.
• Perform MedDRA coding for adverse events, medical history, and medications.
• Process Individual Case Safety Reports (ICSRs) according to client guidelines and regulatory standards.
• Conduct case follow-ups to obtain missing information and ensure complete documentation.
• Maintain high-quality standards in safety data entry and case processing.
• Work with internal teams and supervisors to resolve case queries or discrepancies.
• Follow standard operating procedures and regulatory requirements for safety reporting.
• Contribute to maintaining compliance with global pharmacovigilance guidelines.
• Participate in training programs and continuous learning initiatives related to drug safety.

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 operations.
• Understanding of pharmacovigilance processes and safety case management.
• Strong attention to detail and ability to manage large volumes of safety data.
• Ability to work collaboratively within a team environment.
• Adaptability and willingness to learn new systems, processes, and regulatory updates.

Educational Requirements
• Bachelor’s degree in Pharmacy, Physiotherapy, Nursing, or related healthcare field.
• Basic understanding of clinical safety reporting and pharmacovigilance workflows.
• Knowledge of MedDRA terminology and global safety reporting standards is beneficial.

Experience and Skills
• 1 to 3 years of experience in pharmacovigilance operations or clinical safety roles.
• Familiarity with pharmacovigilance safety databases and ICSR processing.
• Knowledge of adverse event reporting and drug safety monitoring.
• Strong analytical and problem-solving skills.
• Good communication skills for interacting with team members and supervisors.
• Ability to follow detailed instructions and maintain high-quality standards.

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

Company Overview
Accenture is a global professional services company known for its expertise in digital transformation, cloud technology, and business operations. With more than 784,000 employees across over 120 countries, Accenture helps organizations deliver innovative solutions through technology and human ingenuity. Within the Life Sciences R&D vertical, Accenture provides services that support pharmaceutical and healthcare companies across clinical trials, pharmacovigilance, regulatory affairs, and patient services. By combining scientific expertise with advanced technology platforms, Accenture helps biopharma companies accelerate research, maintain compliance, and improve patient outcomes worldwide.

FAQs
• What is the primary responsibility of this role?
Managing pharmacovigilance case processing and monitoring adverse event reports to ensure patient safety and regulatory compliance.

• Will this role involve working with safety databases?
Yes, employees will work with pharmacovigilance databases to manage Individual Case Safety Reports and perform MedDRA coding.

• Is prior pharmacovigilance experience mandatory?
Candidates with 1 to 3 years of experience in pharmacovigilance, drug safety, or clinical research are preferred.

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