At Novo Nordisk Research & Development, GD GSC, our trust in our employees has always been one of the cornerstones of the way we work. Working here, you’ll be part of a team of the best and brightest in your field, where scientific integrity is standard and shared responsibility taken for granted. We use our skills, dedication and ambition to make a change in the lives of many people with chronic diseases in our own way. You will get the opportunity to take part in this, and in addition enhance your career, benefiting from the possibilities for professional and personal development provided by Novo Nordisk.
Requisition ID – 219890BR
Title – Medical Safety Writer
Major Activities (Describe main activities)
1. Lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (RA, Cli nical,
2. Author along with Global Medical Safety Physicians, regulatory periodic safety reports (Periodic
Safety Update Reports, US Periodic Safety Reports) for newly launched Novartis products:
collecting, organizing, analyzing, presenting the data and drafting safety medical
evaluations by means of CMO&PS 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 CMO&PS
5. Drive and Lead CMO&PS projects to develop new PSUR processes in alignment with
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
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
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
12. Act as Subject Matter Expert in cross-functional projects and external meetings.
13. Train and mentor new CMO&PS 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.
- 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 environment and across functions
- Strong organizational and project management skills
- Ability to lead global and cross-functional work groups
- Ability to mentor and coach