Job : Medical Safety Writer - Novartis Healthcare Private Limited

Position Title      : Medical Safety Writer
Job ID                 : 81665BR
Company Name  : Novartis Healthcare Private Limited

Location              : Hyderabad, India
Qualification       : MD or Healthcare Professional
Experience          : 7-10 years in pharmacovigilance
Major Activities :

*Lead/Co-Lead cross-functional teams contributing to periodic safety reports in accordance with DS&E business rules, standard operating procedures and global regulatory requirements.

*Author with Global Medical Safety Physicians regulatory periodic safety reports (Periodic Safe-ty Update Reports, Addendum Reports, Bridging Documents), collecting, organizing, analyzing and presenting the available data in line with DS&E templates & procedures and Health Au-thorities assessments.

*Review Risk Management Plans in close coordination with Pharmacovigilance Compliance and Global Medical Safety groups and assess the operational feasibility and implications of phar-macovigilance commitments.

*Provide a summary evaluation of the medical complaints including corrective measures for assigned marketed products (Annual Product Review document)

*Assist the Medical Safety Physicians in monitoring the safety profile of post marketing prod-ucts.

*Act as liaison between Medical Safety Physicians and Clinical Safety Scientist.

*Lead/Co-lead development/maintenance of safety documents templates and SOPs for the global periodic reports

*Review of regulatory guidelines and identification of impact on DS&E processes

*Provide subject matter training at Global DS&E meetings

*Train and mentor new medical safety writer in DS&E.

*Participate in the recruitment of new medical safety writer in DS&E.

*Deputize for the Clinical Safety Team Leader and assist with departmental activities.

*As a member of Safety Profiling Teams, ensure that case reports are accurately evaluated and databased, authoring or contributing to Product Guidance Documents for assigned products. Work with external partner groups, e.g. co-licensing partners and Clinical Research Organisa-tions to meet joint accountabilities.

*Contribute to DS&E project activities to develop new PSUR processes in alignment with inter-national regulations.

*Support licensing activities, regulatory authority inspections and internal audits. Minimum requirements Education (minimum/desirable): MD or Healthcare Professional with 7-10 years in pharmacovigilance

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