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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | NGO / Social Work |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Your responsibilities include, but are not limited to:
Provide support to TA according to the needs for delivery activities, i.e. ICSR Medical review; co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. Assist TA Safety Leads in monitoring the safety profile of products including with activities such as literature review, medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects or signal detection. Medical review of single case reports will be performed by associates possessing medical degree. Perform Literature review for PSUR inclusion and assessment of literature for ICSRs. Provide support for the preparation of ad hoc Health Authority queries for TA, provides input into responses to inquiries from health care professionals on safety issues. Together with the Safety Leads under minimal supervision, co-author and medically review the PSUR sections, including analytical input to PSUR for identified and potential risks defined in the Risk Management Plan (RMP) and new safety signals. Perform follow up activities on Health Authority Assessment Reports. Assist in providing safety input to Regulatory Affairs and clinical documents (for CDS and IB RSI), support maintenance and management of local deviations (SMPC, USPI, Japanese PI). Assist in evaluating and writing other safety deliverables including but not limited to Clinical Overview, Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR). May deputize for PVLs as agreed with the Head Medical Safety Expert Office. Provide safety input (Addendum to Clinical Overview) for license renewal documents. Provide support as needed for new indication submission (regulatory document safety input). Co-author medical assessment of product quality issues. Facilitate the preparation of Product Guidance Documents (PGDs) for marketed products. Contribute to the development and update of RMPs in collaboration with Safety Leads coordination with other functions, and tracking. Prepare responses to internal safety requests and contribute responses to external safety queries Minimum requirements Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required. Medical degree is essential for associates performing MR Good knowledge/fluency in English. Knowledge of other languages desirable 3+ years of PV, Medical practice or Clinical Drug Development experience post MBBS. Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries. Excellent understanding of clinical trial methodology, ICH GCP , GVP guidelines and medical terminology. Attention to detail and quality focused Strong organizational and project management skills. Strong negotiation and communication skills, and the ability to operate effectively in an international environment Excellent understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process Strong technical understanding of Biomedical/Biostatics concepts and problem solving skills. Good presentation skills Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applications.
,Keyskills :
healthcareprofessionals musicmaking medicalreview riskmanagement medicalwriting computerskills problemsolving productquality drugdevelopment humanphysiology projectmanagement regulatoryaffairs presentationskills communicationskills internati