Director-Clinical Safety & Pharmacovigilance

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

Job summary

Soterius in India seeks a Director - Clinical Safety & Pharmacovigilance to provide strategic and operational leadership across PV activities for clinical trials and post‑authorization products.

You will oversee medical review, signal management, aggregate reporting, quality, and compliance, ensuring adherence to global regulations and client agreements while guiding a high‑performing team.

Qualifications

• Medical Degree (MBBS/MD) required.
• 15+ years of progressive PV/clinical safety experience.
• Medical review of ICSS/SAEs in trials and post‑marketing.
• Signal detection and risk management experience.
• DSURs/PSURs/PBRERs preparation and review.
• Experience with innovator molecules across therapeutic areas.

Responsibilities

• Provide strategic and operational leadership for PV and clinical safety projects.
• Oversee medical review of ICSR data from trials and post‑authorisation sources.
• Lead signal detection, evaluation and management activities.
• Oversee aggregate safety reports (DSURs, PSURs/PBRERs) and regulatory deliverables.
• Ensure global regulatory compliance, SOPs, and audits.
• Manage projects, stakeholders, and safety governance.
• Develop and mentor PV team members and capabilities.

Education

Medical Degree (MBBS/MD)

15+ years of PV/clinical safety experience

Leadership experience

Regulatory knowledge of global PV regulations

Medical review and ICSS/SAE assessment

Signal detection & risk management

DSURs/PSURs/PBRERs preparation

Cross-functional stakeholder management

Tools

None

Job description

Role Summary:

Director - Clinical Safety & Pharmacovigilance will provide strategic and operational leadership across pharmacovigilance and clinical safety activities for clinical trial and post-authorization products. This role is responsible for end-to-end oversight of safety surveillance, medical review, signal management, aggregate reporting, compliance, quality, and team leadership, ensuring adherence to global regulatory requirements, client agreements, and industry best practices.

Key Responsibilities:

1. Strategic & Operational Leadership Provide overall leadership and ownership of assigned pharmacovigilance and clinical safety projects. Ensure effective planning, execution, and delivery of PV activities in line with client agreements, timelines, and quality expectations. Act as a senior medical and scientific authority for safety-related decisions across products and therapeutic areas. Support organizational growth by identifying process improvements, efficiencies, and best practices within pharmacovigilance operations.
2. Medical Review & Safety Assessment Conduct and oversee medical review and assessment of Individual Case Safety Reports (ICSRs) from clinical trials and post-authorization sources. Determine case reportability, seriousness, expectedness, and causality/relatedness. Review case narratives, source documents, adverse event selection, and MedDRA coding to ensure medical accuracy and regulatory compliance. Perform medical and scientific evaluation of safety data including ICFS, signal reports, aggregate reports, and other safety information.
3. Signal Management & Risk Management Lead and oversee signal detection, evaluation, and management activities for innovator and marketed products. Implement and review signal detection methodologies in accordance with regulatory guidance. Contribute to clinical safety strategy, risk management planning, and benefit-risk assessments. Support ongoing safety surveillance and proactive risk identification across the product lifecycle.
4. Aggregate Reporting & Regulatory Deliverables Oversee and provide medical review for aggregate safety reports, including DSURs, PSURs/PBRERs, and other regulatory submissions. Ensure timely preparation, high-quality medical content, and compliance with global regulatory requirements. Collaborate with cross-functional stakeholders to support regulatory submissions and responses.
5. Quality, Compliance & Documentation Ensure compliance with applicable global regulations, guidelines, internal SOPs, and client-specific processes. Maintain oversight of quality, compliance, and documentation across all assigned PV projects. Author, review, and approve SOPs, work instructions, and other functional documents as assigned. Represent the function during internal audits, client audits, and regulatory inspections.
6. Project & Stakeholder Management Oversee project management activities, including workload planning, prioritization, and issue resolution. Communicate effectively with internal and external stakeholders, including clients, vendors, and cross-functional teams. Monitor project risks and elevate concerns related to quality, resourcing, or timelines to functional leadership.
7. People Leadership & Talent Development Provide line management and leadership to assigned team members. Guide, mentor, and develop team members to ensure high performance and professional growth. Identify training needs and support ongoing learning and capability building within the function. Monitor team workload and capacity, proactively addressing resourcing or performance challenges.
8. Additional Responsibilities Perform other pharmacovigilance and clinical safety activities as assigned to meet evolving organizational and client needs.

Qualifications & Experience

• Medical Degree (MBBS/MD required).
• 15+ years of progressive experience in pharmacovigilance and clinical safety, including:
  • Medical review of ICSS (SAEs in clinical trials and post-marketing)
  • Signal detection and signal management
  • Preparation and medical review of DSURs, PSURs/PBRERs
  • Experience working with innovator molecules and across multiple therapeutic areas.
• Strong knowledge of global pharmacovigilance regulations and guidelines.
• Demonstrated leadership experience with strong decision-making and stakeholder management skills.
• Excellent written and verbal communication skills.