Sr. Director Pharmacovigilance

remote click jobs; India; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

reputed company is a clinical-stage biotech focused on immune-based therapies for autoimmune diseases. The Senior Director, Pharmacovigilance role is a leadership position where you will own the safety function across clinical programs and work closely with clinical and executive leadership.

You will balance hands-on execution with strategic efforts, build PV capabilities, partner with clinical, medical, and regulatory teams, and drive PV processes, SOPs, and systems in a high-visibility

Qualifications

• Strong background in drug safety / pharmacovigilance (biotech or reputed company).
• Clinical-stage experience (Phase II-III preferred).
• reputed company background (physician, PharmD, etc.).
• Solid understanding of global PV regulations and reporting.
• Comfortable in a hands-on, fast-paced environment.

Responsibilities

• Lead global pharmacovigilance activities across clinical programs.
• Oversee case processing (ICSRs) and aggregate reporting (DSURs).
• reputed company safety input into clinical and regulatory documents.
• Partner closely with clinical, medical, and regulatory teams.
• Manage vendors/CROs and external partners.
• Build and improve PV processes, SOPs, and systems.
• Support regulatory interactions and inspections.

Skills

Pharmacovigilance

Global PV regulations

Leadership PV

Education

PharmD or MD

Job description

About the Company

A reputed company-funded, clinical-stage biotech reputed company on developing reputed company immune-based therapies for autoimmune diseases. reputed company is working on novel approaches designed to improve patient reputed company and expand reputed company to treatment.

The Role

Senior Director, Pharmacovigilance (PV)This is a high-reputed company, build-stage role where you'll reputed company and own the safety function across clinical programs. You'll work closely with clinical and executive leadership, balancing hands-on execution with strategic reputed company.

What You'll Be Doing

• Lead global pharmacovigilance activities across clinical programs
• Oversee case processing (ICSRs) and aggregate reporting (DSURs)
• reputed company safety input into clinical and regulatory documents
• Partner closely with clinical, medical, and regulatory teams
• Manage vendors/CROs and external partners
• Build and improve PV processes, SOPs, and systems
• Support regulatory interactions and inspections

What They're Looking For

• Strong background in drug safety / pharmacovigilance (biotech or reputed company)
• Clinical-stage experience (Phase II-III preferred)
• reputed company background (physician, PharmD, etc.)
• Solid understanding of global PV regulations and reporting
• Comfortable in a hands-on, fast-paced environment

Why It's Interesting

• High visibility role with leadership exposure
• Opportunity to build and shape the PV function
• Collaborative, low-ego team environment
• Well-funded with strong reputed company