Pharmacovigilance Operations Associate

Why This Role Matters
Pharmacovigilance professionals play a crucial role in ensuring the safety and effectiveness of medicines throughout their lifecycle. Within global pharmaceutical organizations, the monitoring and evaluation of drug safety data is essential for protecting patient health and maintaining regulatory compliance. Aggregate reporting and risk management activities help identify safety trends, evaluate benefit–risk profiles, and communicate critical safety information to regulatory authorities and healthcare stakeholders.
In this role, the Pharmacovigilance Operations Associate supports the preparation, coordination, and quality review of aggregate safety reports and risk management deliverables. These reports are essential for regulatory submissions and ongoing safety monitoring of pharmaceutical products. By ensuring accurate documentation, compliance with regulatory guidelines, and timely report submission, the associate contributes directly to patient safety and global pharmacovigilance standards.
Working with a leading pharmaceutical organization like Novartis provides exposure to advanced drug safety systems, global regulatory frameworks, and cross-functional collaboration within the pharmacovigilance ecosystem.

Job Description
Novartis is seeking a Pharmacovigilance Operations Associate to support the Aggregate Reports and Risk Management (AR&RM) team within the Patient Safety and Pharmacovigilance (PS&PV) department. The role focuses on supporting the preparation, coordination, and tracking of pharmacovigilance deliverables related to aggregate safety reports and risk management documentation.
The associate will assist in retrieving data from global safety databases, conducting quality checks of safety reports, managing report schedules, and ensuring regulatory compliance. The role also involves coordinating with internal teams and licensing partners, supporting project management activities, and maintaining documentation for audit and inspection readiness.
This position is well suited for life sciences professionals who want to develop expertise in pharmacovigilance operations, safety reporting, regulatory compliance, and pharmaceutical risk management.

Key Features of the Role
• Job Title: Pharmacovigilance Operations Associate / Aggregate Reports & Risk Management Associate
• Department: Patient Safety & Pharmacovigilance (PS&PV)
• Organization: Novartis
• Functional Area: Aggregate Reporting & Risk Management
• Industry: Pharmaceutical & Drug Safety
• Work Environment: Global pharmacovigilance operations team

Responsibilities

Aggregate Report Preparation
• Support the preparation of assigned aggregate safety reports and risk management documentation.
• Retrieve safety data from global pharmacovigilance databases according to company SOPs.
• Assist in compiling data and preparing report sections for regulatory submission.

Quality Review and Compliance
• Perform quality control checks to ensure information presented in reports is accurate, complete, and consistent with source data.
• Ensure reports comply with regulatory requirements, internal standards, and organizational templates.
• Maintain proper documentation practices to support audit and inspection readiness.

Operational Coordination
• Support scheduling and coordination of AR&RM deliverables across product portfolios.
• Coordinate report preparation timelines and ensure deadlines are met.
• Assist with the dispatch and publication of assigned safety reports.

Data Management and Tracking
• Maintain tracking systems for AR&RM deliverables using internal tools and SharePoint platforms.
• Collect and analyze data to prepare operational metrics and compliance reports.
• Monitor performance indicators related to pharmacovigilance operations.

Collaboration and Partner Coordination
• Coordinate with licensing partners and internal stakeholders to ensure alignment on safety reporting responsibilities.
• Facilitate document collection, distribution, and archiving of regulatory documents such as certificates and signatures.
• Support communication activities through management of shared mailboxes.

Audit and Inspection Support
• Maintain documentation and records required for regulatory audits and inspections.
• Support archival activities and documentation tracking to ensure compliance readiness.
• Assist in preparation and follow-up of RCA (Root Cause Analysis) and CAPA (Corrective and Preventive Action) activities.

Automation and Operational Excellence
• Participate in automation initiatives aimed at improving pharmacovigilance processes.
• Support the implementation of advanced digital tools and artificial intelligence solutions for operational efficiency.
• Assist in testing and validating pharmacovigilance safety systems and IT applications.

Administrative and Operational Support
• Manage inbound and outbound communications related to AR&RM operations.
• Assist in preparation of compliance reports and quarterly updates for senior management and regulatory offices.
• Support onboarding and training of new team members on AR&RM processes and systems.

Required Qualifications
• Bachelor’s Degree in Life Sciences, Pharmacy, or related healthcare discipline.
• Basic understanding of pharmacovigilance processes and safety reporting requirements.
• Familiarity with aggregate safety reporting and risk management processes is preferred.

Educational Requirements
Candidates should possess one of the following qualifications from a recognized institution:
• Bachelor’s Degree in Life Sciences
• Bachelor’s Degree in Pharmacy or related healthcare discipline
• Master’s Degree in Life Sciences or related field
These qualifications provide the scientific and regulatory foundation needed to understand drug safety monitoring, pharmacovigilance reporting, and regulatory compliance processes.

Experience and Skills

Experience
• Relevant experience in pharmacovigilance operations, drug safety reporting, or regulatory documentation is preferred.
• Experience supporting aggregate safety reports or risk management activities is advantageous.

Technical Skills
• Familiarity with pharmacovigilance safety databases and reporting tools.
• Knowledge of documentation management systems, SharePoint, and tracking tools.
• Proficiency in Microsoft Office applications for reporting and data management.

Professional Skills
• Strong attention to detail and accuracy in documentation.
• Good organizational and project coordination skills.
• Ability to manage multiple deliverables and meet regulatory deadlines.
• Strong communication and collaboration skills.
• Commitment to compliance, quality, and regulatory standards.

Salary Insights
Pharmacovigilance operations professionals typically receive competitive compensation packages depending on experience, role complexity, and organizational structure. In large pharmaceutical companies, employees may also benefit from professional development programs, global exposure, and opportunities for career progression in drug safety and regulatory affairs.

Company Overview
Novartis is one of the world’s leading pharmaceutical companies dedicated to reimagining medicine to improve and extend people’s lives. The company focuses on developing innovative medicines, advanced therapies, and cutting-edge healthcare solutions.
With a strong global presence and a commitment to research and development, Novartis plays a vital role in advancing healthcare through scientific innovation. Its Patient Safety and Pharmacovigilance teams ensure that medicines meet the highest safety standards and comply with international regulatory requirements.

FAQs

Q1. What is the main responsibility of this role?
The role focuses on supporting the preparation, tracking, and quality review of pharmacovigilance aggregate reports and risk management deliverables.

Q2. What type of reports are handled in this role?
The role supports aggregate safety reports, risk management documentation, and compliance reports related to pharmacovigilance activities.

Q3. What skills are important for this position?
Strong documentation skills, attention to detail, project coordination abilities, and knowledge of pharmacovigilance systems are essential.

Q4. Does this role involve regulatory compliance?
Yes, the role ensures that safety reports comply with regulatory requirements and organizational standards.

Q5. What career growth opportunities are available?
Professionals can progress to roles such as Senior Pharmacovigilance Associate, Safety Reporting Specialist, Risk Management Specialist, or Pharmacovigilance Manager.

Application Tips

• Highlight experience in pharmacovigilance, drug safety, or regulatory documentation.
• Mention knowledge of aggregate safety reports and risk management processes.
• Emphasize organizational and documentation management skills.
• Demonstrate experience with compliance tracking and safety reporting tools.
• Showcase the ability to manage multiple deliverables and meet strict regulatory timelines.