Senior Physician Job at ParaxelÂ
Are you looking for a Senior Physician Job in India with a leading global clinical research organization? Parexel is hiring experienced medical professionals for the role of Senior Physician, Patient Safety. This remote opportunity is ideal for candidates with expertise in pharmacovigilance, drug safety, and clinical medicine who are seeking rewarding Paraxel Jobs in India with strong career growth and global exposure.
About the Company
Parexel is a globally recognized clinical research organization specializing in clinical trials, regulatory consulting, pharmacovigilance, and patient safety services. The company works with the pharmaceutical, biotechnology, and medical device industries to accelerate drug development and improve patient outcomes worldwide. Parexel offers excellent remote career opportunities, professional development, and global exposure for healthcare and life sciences professionals.
Job Overview
- Role: Senior Physician, Patient Safety
- Location: India, Remote
- Job ID: R0000039557
- Category: Medical Sciences
- Company: Parexel
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
- 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 Responsibilities
- Performing medical review of cases, including complex and challenging cases requiring expert judgment
- Reviewing clinical trial and literature cases, including combination products {drug-device}, according to client/Parexel Standard Operating Procedures (SOPs)
- Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing the company causality
- Reviewing the appropriateness of medical content in a narrative for medical coherence
- Assessing seriousness, listedness / expectedness of reported events
- Providing medical inputs to the case processing team
- Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
- Reviewing and verifying the appropriate selection of adverse events from source documents
- Assigning an appropriate Medical Dictionary for Regulatory Activities (MedDRA) code and reviewing the narrative
- Identifying and resolving case issues and coordinating with the client’s therapeutic/legal team
- Providing guidance to junior physicians on case assessment methodologies
Qualifications
- 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.)
Experience Required
- 3 Years of relevant experience in pharmacovigilance
- Good knowledge/understanding of medical terminology
- Experience mentoring junior team members
- Experience in clinical medicine (general or specialist qualifications)
Skills Needed
- Good knowledge of drug safety and the drug development process
- Strong knowledge of international drug regulation, including ICH GCP, GVP, and all other applicable regulations and guidelines
- Ability to work on complex tasks requiring in-depth evaluation
- Demonstrated success in technical proficiency and scientific creativity
- Good presentation and verbal/written communication skills
- Good interpersonal skills
- Client-focused approach to work
- Computer proficiency with web-based applications, Windows operating system, and Microsoft Office apps
- Ability to comprehend various regulatory or client requests and strategize a handling approach
- Flexible attitude with respect to work assignments and new learnings
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Ability to assess the clinical relevance of medical data and interpret its clinical meaning
- Willingness to work in a matrix environment and value teamwork
If you are searching for a Senior Physician Job, this remote opportunity at Parexel is one of the best Parexel Jobs in India for experienced pharmacovigilance and patient safety professionals looking to advance their medical career in the clinical research industry.
