Paraxel Drug Safety Physician Post, Freshers MBBS/MD Apply Online
Paraxel Drug Safety Physician Post, Freshers MBBS/MD Apply Online. Interested and eligible applicants can check out all of the details on the same below:
Parexel is a global clinical research organization focused on improving the world’s health. Our team shares a common goal of ensuring better health outcomes through clinical trials, regulatory services, consulting, and market access solutions. We are driven by a strong belief in the impact of our work on patients’ lives.
Job Title: Drug Safety Physician
Location: India-Mohali
Job Purpose:
- Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
- Signal detection/analysis/evaluation and ongoing safety surveillance activities
- Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety
- Provide medical advice/input for narratives written for Clinical Study Reports (CSRs)
- Provide medical, safety input and review of all required safety reports, Benefit Risk Assessment, Safety Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert Statement, Investigator notification letters
- Function as pharmacovigilance representative/safety scientist.
Knowledge and Experience:
- Good knowledge of medical terminology.
Education:
- Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred.
- Graduation/Post Graduation in Medicine.
General:
- Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations
- Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
- Maintaining excellent knowledge of the safety profile of assigned products
- Communicating and discussing issues related to review process with Project Manager
- Interacting with internal and external contacts for resolving issues
- Maintaining a good working knowledge of relevant regulatory guidelines
- Attend and present client/cross functional meetings along with other stakeholders
Case report Medical review
- Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required
- Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
- Assessing seriousness and expectedness of reported events
- Providing medical advice to case processing team
Literature review
- Review of literature for product safety assessment and potential safety issues
Skills:
- Excellent interpersonal, verbal and written communication skills
- Review of literature for product safety assessment and potential safety issues
- Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system
- Client focused approach to work
- A 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 to interpret its clinical meaning is essential
- Willingness to work in a matrix environment and to value the importance of teamwork
- Strong knowledge of international drug regulation including GCP, GVP
Keywords: Drug Safety Physician, Parexel, Clinical Research Organization, Pharmacovigilance, Medical Review, Adverse Event, Regulatory Compliance, Freshers jobs
