Associate Director/Director - Clinical Safety & Pharmacovigilance

Soterius, Inc.; Dadri; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Soterius, Inc. seeks a senior pharmacovigilance leader to drive strategic and operational PV programs. You will oversee ICSR processing, safety operations, and global regulatory compliance across trials and post-marketing activities.

You will mentor teams, manage client relationships, and lead audits and CAPA initiatives while driving continuous improvement and risk management in a global matrix environment.

Qualifications

• Bachelor's/Postgraduate degree in Pharmacy, Life Sciences, Medicine, Nursing, Biotechnology, or related discipline.
• Associate Director: typically 12+ years of relevant experience.
• Director: typically 15+ years of relevant experience with leadership responsibility.

Responsibilities

• Provide strategic and operational leadership for pharmacovigilance projects and teams, ensuring quality and timely delivery.
• Oversee safety operations including ICSR processing for trials and post-marketing activities, per regs and SOPs.
• Ensure compliance with global PV regulations, quality standards, and client requirements.
• Mentor teams, including resource planning, performance management, training, and capability development.
• Act as senior point of contact for internal and external stakeholders and manage client relationships.
• Drive continuous improvement and efficiency across assigned functions.
• Lead audits and regulatory inspections; oversee responses and CAPA implementation.
• Monitor quality metrics, identify risks, and ensure escalation/resolution.
• Review and approve relevant SOPs, work instructions, and reports.
• Support strategic initiatives and new project implementations.

Skills

PV leadership

ICSR processing

Regulatory knowledge

Risk management

Stakeholder mgmt

Audit support

People leadership

Education

Pharmacy or Life Sciences degree

Advanced degree (PG)

Job description

Key Responsibilities

• Provide strategic and operational leadership for assigned pharmacovigilance projects and teams, ensuring quality, compliance, and timely delivery.
• Oversee safety operations, including ICSR case processing for clinical trials and post-marketing activities, in accordance with applicable regulations, SOPs, and client requirements.
• Ensure compliance with global pharmacovigilance regulations, quality standards, contractual commitments, and internal processes.
• Lead and mentor teams, including resource planning, performance management, training, and capability development.
• Act as a senior point of contact for internal and external stakeholders and effectively manage client relationships.
• Drive continuous improvement, process optimization, standardization, and operational efficiency across assigned functions.
• Provide leadership and representation during client audits, internal audits, and regulatory inspections; oversee responses and CAPA implementation.
• Monitor quality and operational metrics, identify risks/issues, and ensure timely escalation and resolution.
• Review and approve relevant SOPs, work instructions, reports, and other functional documentation.
• Support strategic initiatives, new project implementations, business development activities, and other organizational priorities.

Required Skills & Experience

• Strong knowledge of pharmacovigilance, drug safety, and global regulatory requirements.
• Significant experience in pharmacovigilance/safety operations, quality, or a related pharmaceutical/healthcare environment.
• Proven experience in people leadership, project management, client/stakeholder management, and audit/inspection support.
• Strong leadership, communication, analytical, decision-making, and problem-solving skills.
• Ability to work independently, manage multiple priorities, and operate effectively in a global/matrix environment.
• Experience in process improvement and quality/compliance management.

Educational Requirements

• Bachelor's/Postgraduate degree or equivalent in Pharmacy, Life Sciences, Medicine, Nursing, Biotechnology, or another relevant scientific/healthcare discipline.
• Associate Director: Typically, 12+ years of relevant experience.
• Director: Typically,15+ years of relevant experience, with significant leadership and strategic responsibilities.