About Parexel:
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart.
About the Role:
We are seeking a Drug Safety Physician to join our team in Remote capacity. As a Drug Safety Physician, you will play an important role in supporting pharmacovigilance and drug safety activities that help protect patient safety throughout the product lifecycle. This position contributes to medical review, safety surveillance, aggregate reporting, signal management, literature review, and medical monitoring activities across clinical development and post-marketing programs.
You will collaborate with cross-functional teams, clients, and stakeholders to evaluate safety information, ensure compliance with global pharmacovigilance requirements, and support timely safety reporting. Responsibilities include medical review of adverse event cases, provision of medical guidance to safety teams, support for regulatory safety documentation, and contribution to signal detection and management activities.
You'll join a fast-paced, growth-oriented environment focused on advancing patient safety, supporting regulatory compliance, and strengthening evidence-based decision making. With diverse teams and continuous learning opportunities, the Drug Safety Physician can build expertise across global pharmacovigilance and clinical research programs.
Key Responsibilities:
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Perform medical review of adverse event cases, including spontaneous, clinical trial, literature, and combination product cases, in accordance with applicable procedures and guidelines.
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Assess seriousness, expectedness, listedness, causality, and overall medical relevance of reported safety events.
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Review narratives, medical coding, source documentation, and case content for medical accuracy and consistency.
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Provide medical guidance and support to pharmacovigilance and safety operations teams during case processing activities.
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Support medical monitoring activities through review of adverse events, patient profiles, laboratory data, vital signs, medical history, and concomitant medications.
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Provide medical and scientific input to internal teams, clients, investigators, and study personnel under appropriate supervision.
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Review scientific and medical literature for product safety assessments and identification of potential safety concerns.
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Participate in internal and external meetings and present safety-related information as requested.
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Maintain awareness of global drug safety regulations, reporting obligations, and pharmacovigilance requirements.
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Collaborate with internal and external stakeholders to address safety-related issues and support project objectives.
You’ll thrive in this role if you bring:
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Strengths in medical review, clinical assessment, and scientific communication.
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Experience working in clinical medicine, pharmacovigilance, clinical research, or a regulated healthcare environment.
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The ability to collaborate across teams and communicate clearly with internal and external stakeholders.
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A patient-focused mindset and strong attention to detail.
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Comfort working with safety databases, web-based applications, Microsoft Office tools, and pharmacovigilance processes.
Required Qualifications:
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Bachelor of Medicine, Bachelor of Surgery (MBBS), Doctor of Medicine (MD), or equivalent medical qualification from an accredited medical school.
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Completion of basic clinical medicine training, including residency, internship, or equivalent.
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Fresher or relevant experience in pharmacovigilance, drug safety, clinical practice, or medical data review activities.
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Knowledge of medical terminology and clinical assessment principles.
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Understanding of ICH-GCP, GVP, global drug safety regulations, and applicable pharmacovigilance guidelines.
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Strong communication, organization, analytical, and problem-solving skills.
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Computer proficiency, including experience with Microsoft Office applications and web-based systems.
Preferred Qualifications:
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Experience in pharmacovigilance and medical data review activities.
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Familiarity with global pharmacovigilance processes.
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Demonstrated ability to present medical information effectively and work in cross-functional environments.
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