Job Summary
Parexel is hiring a Drug Safety Physician for a fully Remote position in India. The role involves providing medical review and guidance during the processing of adverse event reports for investigational and marketed products. The physician will play a key role in signal detection, ongoing safety surveillance, and communication with both internal teams and external clients to ensure regulatory compliance and product safety standards.
Key Responsibilities
Conduct medical review of adverse event and adverse reaction reports per client SOPs.
Provide medical guidance and consultation to Drug Safety Associates and specialists.
Analyze and assess causality, seriousness, and expectedness of reported medical events.
Maintain thorough knowledge of product safety profiles, labeling, and global drug safety regulations.
Participate in signal detection, risk assessment, and ongoing pharmacovigilance activities.
Communicate effectively with project managers and cross-functional teams regarding safety issues.
Prepare Pharmacovigilance/MAH comments and ensure compliance with global reporting timelines.
Engage in client and internal meetings, presenting medical assessments as required.
Provide medical advice to the case processing team for proper handling of safety data.
Required Skills & Qualifications
MBBS or MD degree required.
Fresher or relevant experience in pharmacovigilance or drug safety is preferred.
Excellent knowledge of medical terminology and clinical relevance interpretation.
Strong understanding of global pharmacovigilance regulations including GCP, GVP.
Proficient in written and verbal communication.
Ability to handle multiple tasks, prioritize effectively, and work under timelines.
Computer proficiency and familiarity with web-based applications and MS Windows.
Strong teamwork and collaboration abilities in a matrix environment.
Perks & Benefits
Work-from-home flexibility with a fully remote role.
Opportunity to work on global drug safety projects with a leading CRO.
Exposure to international regulatory guidelines and pharmacovigilance practices.
Professional growth in a collaborative and client-focused environment.
Company Description
Parexel is a global leader in clinical research, regulatory consulting, and pharmacovigilance solutions. With a strong focus on improving global health, Parexel partners with top pharmaceutical and biotech companies to deliver innovative drug development services.
Work Mode
Remote | India
Call to Action
Interested in shaping drug safety on a global scale? Apply now to join Parexel’s expert medical team and advance your career in pharmacovigilance.
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