Associate Director / Director – Clinical Safety and Pharmacovigilance

Soterius, Inc.; Dadri; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Soterius, Inc. in Noida invites an Associate Director/Director of Clinical Safety and Pharmacovigilance to lead global safety operations across trials and post-marketing activities. You will oversee case processing, audits, CAPA, and regulatory compliance, while mentoring teams and managing client relationships.

The role requires 10+ years for Associate Director or 12–15+ for Director, with strong leadership, strategic planning, and ability to operate in a matrix environment.

Qualifications

• Bachelor's or postgraduate degree in a relevant scientific discipline.
• 10+ years of pharmacovigilance or safety operations experience for senior roles.
• Demonstrated leadership in audits/inspections and client management.

Responsibilities

• Provide strategic and operational leadership for pharmacovigilance projects and teams, ensuring quality, compliance and timely delivery.
• Oversee safety operations, including adverse event/case processing for clinical trials and post-marketing activities, per regulations and SOPs.
• Ensure compliance with global pharmacovigilance regulations, quality standards and client requirements.
• 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 manage client relationships.
• Drive process improvement, standardization and efficiency across assigned functions.
• Support client audits, internal audits and regulatory inspections; oversee responses and CAPA implementation.

Skills

Pharmacovigilance

Drug Safety

People Leadership

Project Management

Audits & Inspections

Client Management

Regulatory Knowledge

Education

Bachelor's or Master's in Pharmacy/Life Sciences

Job description

Associate Director / Director – Clinical Safety and Pharmacovigilance

10-15 years

Noida

Full-Time

Key Responsibilities

• Provide strategic and operational leadership for assigned pharmacovigilance projects and teams, ensuring quality, compliance, and timely delivery.
• Oversee safety operations, including adverse event/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, 10+ years of relevant experience.
• Director: Typically, 12–15+ years of relevant experience, with significant leadership and strategic responsibilities.