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:
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, Cli n- ical, Marketing).
2. Author along with Global Medical Safety Physicians, regulatory periodic safety reports (Period- ic Safety Update Reports, US Periodic Reports) for newly launched Novartis products: collect- ing, 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 anal- yses.
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 Operat- ing 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 mar- keting 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 phar- macovigilance commitments.
10. Contribute to Safety Profiling Teams to newly launched products to ensure that case reports are accurately evaluated and databased, 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.
Candidate Profile:
MD desirable, PhD or PharmaD as minimum requirement Fluency in English. Knowledge of other languages desirable 5 to 7 years’ experience in Drug Development or closely related areas of responsibility, with a minimum of 3 to 5 years’ experience in safety or medical writing. Excellent understanding of drug development process, GCP and medical terminology Sound expertise in large data set analyses Strong negotiation, presentation and communication skills, and ability to operate effectively in an international envi- ronment and across functions Strong organizational and project management skills Ability to lead global and cross-functional work groups Ability to mentor and coach
Additional Information:
Job ID: 128037BR
Experience: 3-5 Year
Industry Type: Pharma/Biotech/Clinical Research
End Date: 29th Nov, 2013
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