Sr. Director Pharmacovigilance

remote next; India; On-site; INR 5,000,000 - 9,000,000; Full time

Job summary

reputed company is seeking a Senior Director, Pharmacovigilance to lead global PV activities across clinical programs and own the safety function. This high-visibility role partners with clinical and executive leadership, balancing hands-on execution with strategic oversight.

You will oversee case processing, aggregate reporting, vendor management, PV process improvements, and regulatory interactions, while building a strong PV team in a fast-paced biotech environment.

Qualifications

• Strong background in drug safety and pharmacovigilance.
• Clinical-stage experience in PV activities (Phase II–III preferred).
• Understanding of global PV regulations and safety reporting.

Responsibilities

• Lead global pharmacovigilance activities across clinical programs.
• Oversee case processing (ICSRs) and aggregate reporting (DSURs).
• Provide PV input into clinical and regulatory documents.
• Partner 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

Strong background in drug safety

Clinical-stage experience

Physician/PharmD background

Global PV regulations

Hands-on, fast-paced environment

Education

MD/PhD/PharmD or equivalent

Job description

About the Company

About the CompanyA 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