Physician Job at Parexel | Remote Patient Safety Role for MBBS, MD Graduates
This physician job offers an excellent opportunity for experienced medical professionals seeking advanced roles in patient safety and pharmacovigilance. As part of Parexel careers, this remote job opportunity in India is ideal for candidates looking for an MBBS job, MD job, or medicine job focused on safety monitoring, regulatory compliance, and medical leadership.
Job Details
- Job Title: Senior Physician, Patient Safety
- Location: India, Remote
- Job ID: R0000038057
- Category: Medical Sciences
About the Company
Parexel is a leading global organization offering clinical research, regulatory, and pharmacovigilance solutions. Parexel careers provide opportunities for physicians to work on global medicine job initiatives, supporting drug safety, patient protection, and regulatory excellence through innovative and science-driven approaches.
Job Description
Senior Physician, Patient Safety, performs medical, safety monitoring, or pharmacovigilance activities for assigned projects. They provide medical reviews, analysis, and guidance in all required safety reports. Senior Physician, Patient Safety, will act as Subject Matter Expert in therapeutic areas and mentor junior team members while working on complex tasks requiring in-depth evaluation.
Qualifications
Education
- Bachelor of Medicine, Bachelor of Surgery (MBBS)
- Doctor of Medicine (MD)
- Medically qualified from an acknowledged Medical School
- Completion of at least basic training in clinical medicine (residency, internship, etc.)
Skills & Experience
- Experience in clinical medicine
- Knowledge of drug safety and pharmacovigilance
- Ability to manage complex medical and regulatory tasks
- Experience mentoring junior team members
- Strong understanding of international drug regulations
Key Responsibilities
General Responsibilities
- Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
- Maintaining an awareness of global regulatory requirements, reporting obligations, and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
- Communicating and discussing issues related to the review process with the Line Manager/ Project Leader/Designee
- Interacting with internal and external stakeholders for resolving issues
- Attending and/ or presenting at client/cross-functional meetings along with other stakeholders and working as Subject Matter Experts (SMEs)
- Assisting the Project Lead/Functional Lead for audits and inspections
- Provides inputs for process improvements
- Works closely with the Project Lead/Functional Lead for process coordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
- Function as a pharmacovigilance representative/safety scientist
- Attend/support Bid defense meetings
- Actively mentoring Patient Safety Physicians to develop their skills and expertise
Case Report Medical Review
- Performing medical review of cases, including complex and challenging cases requiring expert judgement, clinical trials, and literature cases, including combination products, according to SOPs
- Writing Pharmacovigilance/MAH comments and assessing company causality
- Reviewing the appropriateness of medical content in narratives for medical coherence
- Assessing seriousness, listedness, and expectedness of reported events
- Providing medical inputs to the case processing team
- Raising appropriate follow-up queries for relevant information from reporters/HCPs
- Reviewing and verifying adverse event selection, assigning MedDRA codes, and reviewing narratives
- Identifying and resolving case issues and coordinating with the client’s therapeutic/legal teams
- Providing guidance to junior physicians on case assessment methodologies
Periodic & Aggregate Reports
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Reviewing and/or authoring aggregate reports for medical content and consistency
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Providing medical inputs into regulatory documents, including PBRERs, PSURs, SERs, DSURs, COs, ACOs, HHEs, and HA response documents
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Preparing Clinical Expert Statements and related documents
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Reviewing reports prepared by junior team members for accuracy and completeness
Medical Monitoring
- Answering day-to-day medical and scientific questions and providing medical support
- Reviewing and signing off on adverse event reports for accuracy, clinical importance, severity, and seriousness
- Providing sponsors with periodic safety experience reports
- Attending and presenting at internal and external meetings, including investigator meetings and therapeutic area trainings
- Reviewing and signing off on Data Management listings to identify clinically meaningful trends
- Reviewing technical documents related to patient safety
- Reviewing coding of adverse events, medical history, and concomitant medications
- Supporting preparation of clinical protocols, integrated summaries, journal articles, and related documents
Literature Review & CSR Narratives
- Reviewing literature for product safety assessment and potential safety issues
- Triaging, summarizing, and providing MAH comments for literature references
- Performing a medical review of Clinical Study Report narratives according to guidelines
- Providing medical guidance to PV and study teams
Signal Detection & Risk Management
- Performing signal detection and validation activities within defined timelines
- Authoring and reviewing Signal Evaluation Reports and HA responses
- Managing safety signals using project-specific tools
- Contributing to Safety Management Team meetings
- Training and mentoring junior team members on signal detection methodologies
- Supporting Risk Management Plans and safety surveillance strategies
- Contributing to regulatory submissions and safety assessments
Therapeutic Area Expertise
- Serving as a subject matter expert within the designated Therapeutic Area
- Collaborating with TA Leads to implement strategic plans
- Delivering targeted training programs and mentoring junior physicians
- Participating in scientific forums, presentations, and thought leadership activities
- Supporting innovation and best practices in pharmacovigilance
