Pharmacovigilance Services Associate - Drug Safety & Case Processing

Why This Role Matters
Pharmacovigilance plays a crucial role in ensuring that medicines available in the market remain safe, effective, and reliable for patients worldwide. Monitoring drug safety throughout the product lifecycle helps healthcare organizations identify potential risks and take necessary actions to protect patient health. As a Pharmacovigilance Services Associate at Accenture, you will contribute to the detection, assessment, and prevention of adverse effects associated with pharmaceutical products. Your work will support global drug safety surveillance by ensuring that adverse event reports are accurately captured, analyzed, and reported according to regulatory requirements. By maintaining high-quality safety data and supporting safety reporting processes, you help pharmaceutical companies maintain compliance with international standards while protecting patient well-being. This role offers an opportunity to combine healthcare knowledge with analytical and regulatory expertise while working on global pharmacovigilance operations.

Job Description
The Pharmacovigilance Services Associate will be part of Accenture’s Life Sciences R&D vertical and work within the Clinical, Pharmacovigilance & Regulatory sub-offering. This role focuses on supporting pharmacovigilance and drug safety surveillance activities for pharmaceutical and biotechnology clients. In this role, employees will be responsible for managing safety case processing activities related to Individual Case Safety Reports (ICSRs). The position involves case identification, data entry, MedDRA coding, case processing, submission, and follow-up activities in pharmacovigilance safety databases. All activities must be carried out in accordance with client guidelines, regulatory requirements, and internal standard operating procedures. Employees will work closely with their team members and direct supervisors while performing routine tasks and resolving issues based on established guidelines. The role emphasizes accuracy, attention to detail, and compliance with pharmacovigilance regulations to ensure that all safety data is handled appropriately. The position is structured as an individual contributor role within a team environment, where employees manage a focused scope of work and contribute to overall drug safety monitoring processes. This role may also require working in rotational shifts to support global pharmacovigilance operations and ensure continuous safety monitoring.

Key Features of the Role: Responsibilities
• Perform case identification and intake of adverse event reports from various data sources.
• Enter safety data accurately into pharmacovigilance safety databases.
• Conduct MedDRA coding for adverse events, medical history, and medications.
• Process Individual Case Safety Reports in accordance with client requirements and global regulatory guidelines.
• Manage case follow-up activities to obtain missing information and ensure data completeness.
• Maintain quality standards while performing safety data entry and case processing tasks.
• Work collaboratively with team members and supervisors to resolve queries and discrepancies.
• Follow established standard operating procedures and pharmacovigilance guidelines.
• Contribute to maintaining compliance with global drug safety reporting standards.
• Participate in internal training programs to enhance pharmacovigilance knowledge and operational skills.

Required Qualifications
• Bachelor of Pharmacy, Bachelor in Physiotherapy, or BSc Nursing.
• 1 to 3 years of experience in pharmacovigilance, clinical safety, or related healthcare operations.
• Basic understanding of drug safety reporting and pharmacovigilance processes.
• Strong attention to detail and ability to handle safety data accurately.
• Ability to work effectively within a team environment.
• Adaptability and willingness to learn new processes and systems quickly.

Educational Requirements
• Bachelor’s degree in Pharmacy, Physiotherapy, Nursing, or related healthcare discipline.
• Knowledge of pharmacovigilance workflows, adverse event reporting, and safety case management is advantageous.
• Familiarity with MedDRA coding terminology is preferred.

Experience and Skills
• 1 to 3 years of professional experience in pharmacovigilance or clinical safety operations.
• Experience with safety databases and case processing workflows is beneficial.
• Strong analytical and problem-solving skills.
• Good communication and collaboration skills.
• Ability to follow instructions carefully and maintain quality standards in safety reporting activities.

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

Company Overview
Accenture is a global professional services company with leading capabilities in digital, cloud, and security. With more than 784,000 employees across over 120 countries, the company delivers innovative solutions by combining technology and human expertise. Accenture serves clients across multiple industries including healthcare, life sciences, finance, and technology. The Life Sciences R&D vertical focuses on helping pharmaceutical and biotechnology companies accelerate research, improve clinical trial operations, maintain regulatory compliance, and enhance patient outcomes. By integrating scientific expertise with advanced technology platforms, Accenture supports global healthcare organizations in bringing safe and effective therapies to patients around the world.

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

• Will I work with pharmacovigilance databases?
Yes, employees will use safety databases to process Individual Case Safety Reports and manage safety data.

• Is teamwork important in this role?
Yes, the role involves working closely with team members and supervisors to ensure high-quality safety reporting.

Application Tips
• Highlight any experience related to pharmacovigilance, clinical safety, or adverse event reporting.
• Mention knowledge of MedDRA coding and safety database systems if applicable.
• Emphasize your attention to detail, teamwork skills, and ability to learn quickly.
• Tailor your resume to demonstrate your understanding of pharmacovigilance processes and regulatory compliance.