Clinical Safety Manager NCE (Manager or Sr. Manager)
About the Role
Role & Responsibilities
• Oversee clinical and post-marketing safety strategies for NCEs
• Lead signal management and benefit-risk evaluation for clinical trials
• Manage regulatory interactions and health authority queries
• Review DSURs, PSURs, PBRERs, and other safety-related documents
• Provide medical input for clinical development programs
Qualification
• MBBS / MD / PhD in Life Sciences / Pharmacy
Experience
• 7–8 years of clinical and post-marketing pharmacovigilance experience
• Strong exposure to global submissions and regulatory frameworks
Skills
• Expertise in clinical safety strategy and regulatory submissions
• Strong leadership and management skills in pharmacovigilance
• Proficient in writing and reviewing regulatory safety documents
About the Company
• Sun Pharmaceutical Industries Ltd. is one of India’s largest global pharmaceutical companies.
• It is a leader in the manufacturing of specialty and generic medications, with a focus on drug safety, regulatory compliance, and patient health.
AI Career Power Suite
Resume Analyst
Unlock refined AI insights.
Interested?
Frequently Asked Questions
Everything you need to know about the process