Novartis Hiring Medical Safety Writer (Aggregate report writing – PSUR, PBRER)

Novartis Hiring Medical Safety Writer (Aggregate report writing – PSUR, PBRER)

23 June, 2022

Novartis Hiring Medical Safety Writer (Aggregate report writing – PSUR, PBRER)

Your responsibilities include, but are not limited to:

  • Lead preparation of global periodic safety reports for newly launched products. Lead coordination with GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements.
  • Independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards
  • Support in creating strategy for data analyses and presentation in global periodic safety reports. Support in addressing the Health Authority (HA) comments adequately in PSURs.
  • Support in the development of safety document templates and Standard Operating Procedures pertaining safety aggregate reports
  • Contribute to global projects focusing on process & quality improvement initiatives. Contribute as subject matter expert during Health Authorities inspections/audits and contribute in development, implementation of appropriate Corrective and Preventative Actions (CAPA).
  • Train and mentor new CMO&PS associates and associates from other line functions on medical safety writing & periodic reporting matters.
  • Support Head, Safety Report Writing/Head, Aggregate reports and assist with the recruitment of new staff.

Minimum Requirements

  • Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree Fluency in English.
  • Knowledge of other languages desirable. 4 to 8 years’ experience in drug safety/ development or closely related areas of responsibility, with a minimum of 3 years’ experience in in safety/ medical/scientific/regulatory writing preferably, at least 2 years of experience in safety writing
  • Sound expertise in data analysis and presentation Strong project management and communication skills. Ability to lead global and cross-functional work groups excellent understanding of drug development.

Apply HERE

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