Patient Safety Physician Job at Parexel
Are you a medical professional passionate about ensuring patient safety in the pharmaceutical industry? Parexel is seeking a Senior Physician in Patient Safety for a remote position in India. This Patient Safety Physician Job offers the chance to provide medical expertise and oversight in pharmacovigilance, contributing to the safety and efficacy of investigational and marketed products. With a focus on regulatory compliance and patient care, this opportunity allows you to work with global stakeholders and make a significant impact in the field of drug safety.
About Parexel:
Parexel is a leading global clinical development partner delivering insight-driven clinical and consulting solutions to the life sciences industry. With over 22,000 employees worldwide, Parexel partners 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. The organisation works with focus, agility, and shared purpose to address patient needs and accelerate the delivery of new therapies.
Job Details:
- Job ID: R0000038064
- Primary Location: India, Remote
- Category: Medical Affairs
About the Role:
Parexel is seeking a Senior Physician, Patient Safety to provide medical expertise and oversight across pharmacovigilance and patient safety activities supporting investigational and marketed products. This role is critical in protecting patient safety, supporting regulatory compliance, and contributing to the ongoing evaluation of product benefit-risk profiles throughout the product lifecycle. Responsibilities include medical review, analysis, and guidance throughout the adverse event and adverse reaction case handling and reporting process.
Key Responsibilities:
- Provide medical review, analysis, and guidance throughout the case handling and reporting lifecycle for adverse events and adverse reaction reports associated with investigational and marketed products.
- Conduct signal detection, analysis, evaluation, and ongoing safety surveillance activities.
- Provide medical guidance and support to patient safety associates and pharmacovigilance specialists on patient safety-related matters.
- Review and provide medical input for narratives prepared for Clinical Study Reports.
- Provide medical review and support for safety reports including PSURs, PBRERs, PADERS, Risk Management Plans, and more in the Patient Safety Physician Job.
- Maintain knowledge of assigned product safety profiles, labeling documents, client procedures, and international patient safety regulations.
- Ensure awareness of global regulatory requirements and reporting obligations to support compliance with internal and regulatory timelines at Parexel Careers.
- Collaborate with project managers, clients, and internal stakeholders to resolve review and safety-related issues.
Eligibility Criteria for the Patient Safety Physician Job:
- Graduation or Post-Graduation in Medicine.
- Relevant experience in pharmacovigilance, patient safety, or a related field.
- Strong knowledge of international patient safety regulations, including GCP and GVP.
- Ability to assess the clinical relevance of medical data and interpret its clinical significance.
- Excellent interpersonal, verbal, and written communication skills.
- Computer proficiency and experience with web-based applications.
- Ability to manage multiple priorities while maintaining quality and attention to detail.
- Ability to work effectively in a matrix environment and collaborate as part of a team.
Required Qualifications for the Patient Safety Physician Job:
- 2+ years of experience in ICSR Medical review or safety surveillance.
- Experience preparing, reviewing, or contributing to aggregate safety reports and regulatory submission documentation.
- Experience supporting risk management planning and benefit-risk assessments.
- Experience training, mentoring, or serving as a subject matter expert within pharmacovigilance operations.
- Experience working with investigational and marketed products in a global regulatory environment.
