Job Posting: Urgent Opening for Drug Safety Physician in Hyderabad, India-MBBS and MD Job Opportunities
Job Posting: Drug Safety Physician
Company: Parexel
Work Location: Hyderabad/Mohali – office based
Key Accountabilities
Supporting Activities General
- Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client 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 the review process with the Project Manager
- Interacting with internal and external contacts to resolve issues
- Maintaining a good working knowledge of relevant regulatory guidelines
- Attend and present client/cross-functional meetings along with other stakeholders
- Training and mentoring new team members, as required
- Working as Subject Matter Experts (SMEs)
- Assisting the Manager with inspection readiness activities and audits
- Provides inputs for process improvisations
- Works closely with the Manager for process coordination and to ensure meeting all KPIs for the process.
Case report Medical review (as applicable)
- 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) comments and assessing company causality
- Assessing the seriousness and expectedness of reported events
- Providing medical advice to DSPs and the case processing team
Periodic reports (as applicable)
- Review and authoring aggregate reports for medical context and consistency in accordance with client requirements and SOPs
- Providing medical advice to case processors for authoring sections
Literature review (as applicable)
- Review of literature for product safety assessment and potential safety issues
CSR Narratives (as applicable)
- Performing medical review of CSR narratives according to the client’s guidelines and SOPs.
Safety Scientist (as applicable)
- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparing of safety surveillance strategy and highlighting and tracking potential issues.
- Support the preparation and maintenance of Risk Management plans.
- Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal, Health Hazard Assessments and other Annual Safety/addendum reports) in accordance with regulatory requirements and standard operating procedures.
- Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels, and Development Core Safety Information (DSCI).
- Coordinate safety activities between PDS and internal and external partners.
- Conduct/support signal detection and evaluation according to SOPs and guidelines.
- Prepare safety assessments, and drug safety reports, as necessary, for potential signals or issues (product quality).
- Perform review and summarization of literature citations including epidemiology background research.
- Provide safety content review of clinical protocols, study reports, Investigator’s Brochure, and other related documents to ensure alignment with the Clinical Development Plan (CDP)
- Contribute to regulatory agency submissions (Investigational New Drug (IND) applications, New Drug Applications (NDA), Marketing. Authorization Application provides (MAA’s), Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages.
- Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable.
Signal Detection and Management (as applicable)
- Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literature, regulatory authority websites, etc.
- Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the Global safety officer (GSO)
- Conduct/support signal detection and evaluation activities according to SOPs and guidelines
Skills For MBBS and MD job Opportunities
- Excellent interpersonal, verbal, and written communication skills
- 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
- The 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
Knowledge and Experience for MBBS and MD Job Opportunities
Relevant experience in Pharmacovigilance/ drug safety is desirable. Experience in a relevant field is preferred.
Education:
Graduation/Post Graduation in Medicine.
How to Apply – Please send your resume to Subramanyam.Turga@Parexel.com
