Director-Clinical Safety & Pharmacovigilance
soterius· Clinical Safety & Pharmacovigilance
About this role
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 ICSRs, 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 escalate 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 ICSRs (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.
Frequently Asked Questions
Is the salary disclosed for the Director-Clinical Safety & Pharmacovigilance position at soterius?
The salary for this Director-Clinical Safety & Pharmacovigilance role at soterius is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Director-Clinical Safety & Pharmacovigilance position at soterius located?
This Director-Clinical Safety & Pharmacovigilance role at soterius is based in Noida, UP, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Director-Clinical Safety & Pharmacovigilance role at soterius full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Director-Clinical Safety & Pharmacovigilance role in the Clinical Safety & Pharmacovigilance department at soterius.
Which team or department does the Director-Clinical Safety & Pharmacovigilance at soterius belong to?
This Director-Clinical Safety & Pharmacovigilance position is part of the Clinical Safety & Pharmacovigilance department at soterius. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Director-Clinical Safety & Pharmacovigilance position at soterius?
Click the "Apply Now" button on this page. You will be redirected to soterius's official application portal hosted on keka where you can submit your application directly.
When was the Director-Clinical Safety & Pharmacovigilance job at soterius posted?
This Director-Clinical Safety & Pharmacovigilance position at soterius was posted on Jun 16, 2026. Apply as soon as possible — early applications are often reviewed first.
Director-Clinical Safety & Pharmacovigilance
soterius
You'll be redirected to soterius's official application page on keka.