Job Title: Drug Safety Physician
Location: India - Mohali
Employer: Parexel
Category: Medical Sciences
Job ID: R0000031430
Job Type: Full-Time
About Parexel:
Parexel is a global leader in providing solutions for the pharmaceutical, biotechnology, and medical device industries. Their mission is to deliver clinical trials that bring innovative treatments to patients faster, ensuring safety and compliance across all stages of the process.
Position Overview:
As a Drug Safety Physician at Parexel, you will be responsible for medical review, analysis, and guidance during the case handling and reporting cycle of Adverse Event (AE) and Adverse Reaction (AR) reports for investigational and marketed products. This role involves signal detection, safety surveillance, and providing medical advice on safety reports, clinical study reports, and other pharmacovigilance-related documents.
Key Responsibilities:
Case Report Medical Review:
Perform medical reviews of cases according to client Standard Operating Procedures (SOPs).
Liaise with clients and assess causality and seriousness of reported adverse events.
Provide medical advice to the case processing team for accurate report writing.
Signal Detection and Safety Surveillance:
Conduct signal detection and safety assessments for investigational and marketed products.
Ensure timely reporting of safety issues and compliance with regulatory timelines.
Medical Guidance and Advice:
Provide guidance to Drug Safety associates and specialists on medical aspects of drug safety.
Offer medical input for clinical study reports (CSRs), Benefit Risk Assessments, and other safety-related documentation.
Literature Review:
Conduct literature reviews for product safety assessment and potential safety issues.
Stay up-to-date with global regulatory requirements, including GCP and GVP.
Client and Cross-Functional Meetings:
Attend client and cross-functional meetings, contributing to safety evaluations and issue resolution.
Collaborate with internal and external stakeholders to resolve any safety concerns.
Required Skills:
Medical Terminology: Strong knowledge of medical terminology and pharmacovigilance processes.
Communication Skills: Excellent interpersonal, verbal, and written communication skills.
Client-Focused: A client-centered approach to work, with a flexible attitude towards new assignments.
Regulatory Knowledge: Knowledge of international drug regulations and pharmacovigilance (GCP, GVP).
Attention to Detail: Ability to manage multiple tasks efficiently and prioritize workload with accuracy.
Qualifications and Experience:
Education: Graduation/Post-Graduation in Medicine.
Experience: Freshers or those with relevant experience in pharmacovigilance or drug safety are preferred.
Why Parexel?
Parexel offers a supportive and collaborative environment with a focus on career development and professional growth. Working at Parexel means contributing to groundbreaking clinical trials and supporting the safety and well-being of patients globally. Additionally, you will have the opportunity to learn from a diverse team and engage in impactful work that improves global health.
Career Advancement:
At Parexel, your career can progress in various paths, whether in leadership, technical expertise, or other areas of medical sciences and pharmacovigilance. The company promotes continuous learning, mentorship, and cross-functional opportunities to help you develop your career to its full potential.
Join Us:
If you're passionate about drug safety and want to make a significant impact in the medical field, Parexel provides a great environment for you to grow and thrive.
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