Job Summary:
Novartis Healthcare Private Limited is hiring a Senior Safety Case Expert for its Hyderabad location. This role is critical for overseeing case processing, ensuring compliance with pharmacovigilance regulations, and leading operational projects. The position offers an excellent opportunity to contribute to global drug safety processes in one of the world’s leading pharmaceutical companies.
Responsibilities:
Monitor case processing activities ensuring ESP quality and compliance.
Perform evaluation and QC of Serious Adverse Events/Post Marketing Adverse Events.
Conduct daily quality review (QR) for Individual Case Safety Reports (ICSR).
Mentor and train team members and ESPs.
Lead process changes, development, and monitoring of process-related metrics.
Prepare and maintain manuals and process documents.
Create and maintain training materials and communications for internal teams and ESPs.
Act as Subject Matter Expert for PS&PV associates and global functions.
Develop and maintain guidance documents and safety management plans.
Support audits/inspections and implement Corrective and Preventive Actions (CAPA).
Address case processing-related Health Authority queries within timelines.
Collaborate with Data Management and Medical Safety Physicians for database locking and safety profile monitoring.
Lead operational projects and support complex validation activities.
Required Skills & Qualifications:
Graduate/Postgraduate/Doctorate in Life Sciences, Pharmacy, or Medical Sciences.
Minimum 8 years of industry experience, including 3-5 years in drug safety or development.
Strong verbal and written communication skills.
Document writing experience preferred.
Self-motivated with a proactive approach.
Strong sense of urgency and commitment to deadlines.
Previous Pharmacovigilance data entry experience desirable.
Ability to work in a global, cross-functional environment.
Perks & Benefits:
Comprehensive benefits and rewards package.
Opportunities for global career growth within Novartis.
Access to learning resources and training for continuous development.
Inclusion in a diverse and supportive workplace environment.
Company Description:
Novartis Healthcare Private Limited is a globally recognized pharmaceutical leader dedicated to transforming patient lives through innovation in drug development, safety, and clinical research. With a strong presence in India, Novartis offers professionals the chance to work on breakthrough therapies in a collaborative environment.
Work Mode:
On-site (Hyderabad)
Call to Action:
If you are ready to make a difference in global drug safety and pharmacovigilance, apply now for the Senior Safety Case Expert position at Novartis. Take the next step in your career by contributing to groundbreaking medical advancements.
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