Specialist – Case Processing
Job Summary:
Cencora, a global healthcare leader, is seeking a highly motivated and detail-oriented Specialist – Case Processing to join our pharmacovigilance team in Noida, India. In this role, you will be responsible for processing and evaluating adverse event reports, ensuring data accuracy, and contributing to the safety surveillance of our pharmaceutical products. This is an excellent opportunity to grow your career in pharmacovigilance, contribute to global drug safety, and mentor new team members.
Responsibilities:
- Perform triage and review of incoming adverse event reports (spontaneous, health authority, clinical trial, and literature cases) to determine initial case validity.
- Enter data accurately and efficiently into the pharmacovigilance (PV) database, ensuring data integrity.
- Conduct initial Individual Case Safety Report (ICSR) assessments, including seriousness, causality, and expectedness.
- Evaluate cases for expedited reporting requirements and ensure timely submission to regulatory authorities.
- Prepare and submit CIOMS I forms, MedWatch forms, and XML submissions to health authorities and partner companies.
- Generate and send follow-up requests to obtain additional information related to adverse event reports.
- Submit ICSRs to health authorities and partner companies according to regulatory timelines.
- Complete thorough case documentation and perform quality control checks to ensure ICSR accuracy and completeness.
- Retrieve ICSRs from EVWEB and perform company/non-company assessments to determine reporting obligations.
- Mentor and provide support to new team members in case processing procedures and pharmacovigilance compliance.
- Maintain a strong understanding of relevant regulations, guidelines, and standard operating procedures (SOPs).
- Participate in training programs to enhance knowledge and skills in pharmacovigilance.
Requirements:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, Nursing, or a related field.
- 2–5 years of experience in pharmacovigilance or case processing is preferred.
- Strong knowledge of ICSR processing, MedDRA coding, and global safety databases.
- Familiarity with expedited reporting requirements, regulatory compliance, and pharmacovigilance guidelines.
- Excellent communication skills, both written and verbal, with the ability to clearly and concisely convey information.
- Exceptional attention to detail and accuracy in data entry and case processing.
- Ability to work independently and as part of a team, demonstrating strong collaboration skills.
- Proficiency in computer skills, including database management and Microsoft Office applications.
- Demonstrated mentoring skills and the ability to guide and support new team members.
Benefits:
Cencora is committed to providing a supportive and rewarding work environment for our employees. We offer a comprehensive benefits package, including:
- Competitive salary commensurate with experience (₹4,50,000 – ₹7,50,000 annually).
- Opportunities for training and professional development to enhance your skills and career growth.
- An inclusive and collaborative work culture that values teamwork and innovation.
- Comprehensive health, wellness, and leave benefits aligned with industry standards to support your well-being.
How to Apply:
If you are a passionate and dedicated professional with a strong interest in pharmacovigilance, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter through the following link:
[Application Link]
[Application Link 2]
We look forward to reviewing your application!