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Medical Safety Writer

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Lead global cross-functional teams responsible for writing periodic safety reports within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating procedures and global regulatory requirements. Responsible for supporting the Global Medical Safety Physicians in the monitoring of the safety profile of newly launched Novartis products.1.Lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing). 2. Author along with Global Medical Safety Physicians, regulatory periodic safety reports (Periodic Safety Update Reports, US Periodic Reports) for newly launched Novartis products collecting, organizing, analyzing, presenting the data and drafting safety medical evaluations by means of DS&E templates and procedures.3. Collaborate with the Medical Safety Physicians and other line functions to monitor the safety profile of newly launched products emerging from aggregate reporting or large data set analyses. 4.Review emerging regulatory guidelines and legislations and identification of impact to DS&E processes.5.Drive and Lead DS&E projects to develop new PSUR processes in alignment with international regulations. 6.Lead the development and maintenance of safety documents templates and Standard Operating Procedures pertaining safety aggregate reports.7.Lead sessions during Health Authorities inspections and audits as Subject Matter Expert, and lead the development and implementation of Corrective and Preventative Actions (CAPA) to address safety findings. 8.Review global marketing programs and establish process for AEs collection with global marketing teams.9.Review Risk Management Plans in close coordination with Pharmacovigilance Compliance and Global Medical Safety groups and assess the operational feasibility and implications of pharmacovigilance commitments. 10. Contribute to Safety Profiling Teams to newly launched products to ensure that case reports are accurately evaluated and database, and have reliable and exploitable data sets when preparing aggregate reports.11. Proactively collaborate with licensing partners and Clinical Research Organizations to meet joint accountabilities. 12. Act as Subject Matter Expert in cross-functional projects and external meetings.13. Train and mentor new DS&E associates and associates from other line functions on medical safety writing & periodic reporting matters. 14. Deputize for Team Leader/Group Head and assist with the recruitment of new staff.15.Ability to lead cross-functional teams and represent DS&E at external meetings. 16.Drive continuous DS&E business improvements by initiating & managing initiatives.17.Number, timeliness and quality of deliverables according to established directives. 18. Role model of company values & behavior.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | MD/ MS (Medicine)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 5-7


Chemical Research | Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control
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