Director – Medical Safety
Location: Kolkata, West Bengal, India
Employment Type: Full-Time | Hybrid
Experience Required: 10+ Years (Clinical Practice and Medical Safety)
Job ID: R1515587
Job Overview
IQVIA, a global leader in clinical research services, healthcare intelligence, and advanced analytics, is seeking a Director – Medical Safety to provide senior medical leadership across pharmacovigilance and clinical safety programs. This role is critical in ensuring patient safety, regulatory compliance, and high-quality medical oversight across clinical development and post-marketing activities.
The position requires a qualified medical professional with extensive experience in clinical practice and medical safety, capable of leading complex safety initiatives and collaborating with global, cross-functional stakeholders.
Key Responsibilities
Provide strategic medical oversight for safety and medical monitoring activities across clinical trials and post-authorization programs.
Ensure compliance with global and regional safety regulations, including ICH-GCP, pharmacovigilance guidelines, and local health authority requirements.
Act as a medical subject matter expert for safety case review, signal detection, risk assessment, and benefit-risk evaluations.
Advise project teams and clients on safety-related issues, regulatory expectations, and risk mitigation strategies.
Collaborate with clinical operations, regulatory affairs, data management, biostatistics, and quality teams to support safe and compliant study execution.
Lead, mentor, and develop medical safety professionals, supporting performance management and capability building.
Contribute to safety governance, process improvement initiatives, and quality enhancement programs.
Support project planning, resource allocation, and financial oversight related to medical safety deliverables.
Required Knowledge, Skills, and Abilities
Strong knowledge of global and local regulations governing clinical research, pharmacovigilance, and medical safety.
In-depth understanding of clinical trials and the pharmaceutical drug development lifecycle.
Proven ability to manage priorities, meet deadlines, and deliver high-quality outcomes across multiple projects.
Demonstrated leadership capabilities with experience in financial and project management.
Excellent consultation, communication, and stakeholder management skills.
Ability to establish and maintain effective working relationships with internal teams, clients, and senior leadership.
Qualifications & Experience
Medical degree (MBBS or equivalent) from an accredited and internationally recognized medical school.
Minimum 5 years of post-qualification clinical practice experience, including residency or graduate medical training.
At least 5 years of experience in medical safety, pharmacovigilance, or medical monitoring within the pharmaceutical, CRO, biotech, or related healthcare industry.
Equivalent combinations of clinical practice and pharmaceutical physician experience are acceptable.
Valid and current medical license (or equivalent) in the country or region of practice.
Experience in global or multi-country clinical programs is highly desirable.
Physical & Work Requirements
Extensive use of telephone, email, and virtual communication tools requiring clear spoken and written English.
Regular use of computers and keyboards for extended periods.
Ability to sit for prolonged durations during the workday.
Willingness to travel up to approximately 10%, based on business or client requirements.
About IQVIA
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. IQVIA creates intelligent connections across data, analytics, and technology to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes worldwide.
Equal Opportunity Employer
IQVIA is committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, religion, gender, age, national origin, disability, sexual orientation, gender identity, veteran status, or any other protected characteristic.
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