Specialist – Pharmacovigilance, Epidemiology & Risk Management
Location: Noida, India
Employment Type: Full-Time
Category: Pharmacovigilance / Consulting
Posted On: December 3, 2025
Job ID: R2519675
Affiliated Entity: PharmaLex India Private Limited (A Cencora Company)
About Cencora
Cencora is a global leader in pharmaceutical services, dedicated to improving health outcomes for people and animals worldwide. Our teams are united by a shared mission to create healthier futures through innovation, compliance excellence, and patient safety. Joining Cencora means working at the center of global healthcare impact while building a meaningful and future-ready career.
Job Overview
Cencora is seeking a Specialist – Pharmacovigilance, Epidemiology & Risk Management to support global drug safety operations. This role is responsible for end-to-end Individual Case Safety Report (ICSR) processing, regulatory submissions, and quality assurance activities in compliance with international pharmacovigilance regulations.
The ideal candidate will bring strong expertise in case processing, regulatory reporting, and safety database management, along with the ability to mentor junior team members in a collaborative environment.
Key Responsibilities
Perform triage and initial validity assessment of adverse event cases, including spontaneous, clinical trial, health authority, and literature cases
Conduct accurate data entry and case processing within pharmacovigilance safety databases
Perform initial ICSR assessments and evaluate the need for expedited reporting based on regulatory timelines
Prepare and submit standard regulatory reporting forms such as CIOMS I, MedWatch, and XML files
Submit ICSRs to global health authorities and client partners in compliance with applicable regulations
Prepare and manage follow-up requests to obtain missing or additional case information
Complete case documentation in accordance with SOPs and project-specific requirements
Conduct quality checks on ICSRs to ensure data accuracy, completeness, and regulatory compliance
Perform ICSR search and retrieval from EudraVigilance (EVWEB) and assess company versus non-company cases
Support pharmacovigilance audits and inspections through accurate documentation and compliance readiness
Mentor and guide new team members by providing training on pharmacovigilance processes and best practices
Execute additional responsibilities as assigned by the supervisor based on project and business needs
Required Qualifications
Education:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, Nursing, or a related scientific discipline
Experience Required:
Minimum 2 to 5 years of hands-on experience in pharmacovigilance case processing or drug safety operations
Proven experience handling ICSRs across spontaneous, clinical trial, and literature sources
Familiarity with global regulatory reporting requirements (US FDA, EMA, MHRA, ICH, CIOMS)
Experience working with pharmacovigilance safety databases and EVWEB
Key Skills & Competencies
Strong understanding of pharmacovigilance regulations and safety reporting standards
High attention to detail and commitment to data quality and compliance
Ability to manage multiple cases and meet strict regulatory timelines
Strong documentation, analytical, and problem-solving skills
Effective communication and collaboration abilities in a global team environment
Mentoring mindset with the ability to support team development
What Cencora Offers
Full-time employment with a globally recognized healthcare organization
Exposure to international pharmacovigilance and regulatory projects
Career development and learning opportunities in drug safety and risk management
A collaborative, inclusive, and compliance-driven work culture
Equal Employment Opportunity
Cencora is an equal opportunity employer and is committed to providing a workplace free from discrimination and harassment. Employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, veteran status, or any other legally protected status.
Reasonable accommodations are available for qualified individuals with disabilities throughout the recruitment process.a
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