A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Medical Safety Writer
Job Description:
1. 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.
2. 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.
3. 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.
4. Provide a summary evaluation of the medical complaints including corrective measures for assigned marketed products (Annual Product Review document)
5. Assist the Medical Safety Physicians in monitoring the safety profile of post marketing prod-ucts.
6. Act as liaison between Medical Safety Physicians and Clinical Safety Scientist.
7. Lead/Co-lead development/maintenance of safety documents templates and SOPs for the global periodic reports
8. Review of regulatory guidelines and identification of impact on DS&E processes
9. Provide subject matter training at Global DS&E meetings
10. Train and mentor new medical safety writer in DS&E.
11. Participate in the recruitment of new medical safety writer in DS&E.
12. Deputize for the Clinical Safety Team Leader and assist with departmental activities.
13. 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.
14. Contribute to DS&E project activities to develop new PSUR processes in alignment with inter-national regulations.
15. Support licensing activities, regulatory authority inspections and internal audits.
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Candidate Profile:
Education (minimum/desirable): MD or Healthcare Professional with 7-10 years in pharmacovigilance
Languages: Excellent written and oral English. Knowledge of other languages desirable.
Experience/Professional requirement:
• At least 3-year or more experience of clinical or safety document writing
• Ability to lead and contribute to DS&E initiatives
Additional Information:
Experience: 7-10 years
Location: Hyderabad
Education: M.Pharm, MS, MD, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, IT
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 81665BR
End Date: 16th June, 2011
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