Your responsibilities include, but are not limited to :
Performs tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs), including tasks assigned in harmonized GOPs / SOPs / WIs as per the role mapping in the applicable role matrix.
Preparation of RMPs and / or Medical Risk Assessments according to legal requirements and internal procedures. Medical Review of RMPs and / or Medical Risk Assessments prepared by colleagues.
Handling of Assessment Reports / Health Authority feedback / questions and preparation of answers to Health Authorities for RMPs and / or Medical Risk Assessments.
Preparation and review of working instructions. Proofreading of RMPs and / or Medical Risk Assessments prepared by external service providers, preparation of feedbacks and quality metrics.
Presents safety issues to the Safety Management Board / other internal boards as needed. Evaluation of Signals / Issues as per internal procedures.
Supports audits and / or inspections as needed.
The SRM Manager (Safety Risk Management) is responsible for the preparation / proofreading and / or updates of documents required for Safety Risk Management;
In particular Risk Management Plans (RMPs), Medical Risk Assessments (MRAs) for Product Quality Investigations, and / or Issue / Signal Detection & Evaluations, for assigned products, including responding to Health Authority and / or internal questions on any of these documents.
The assigned products are all products assigned to the Therapeutic Area Generics as per the IPL.
Minimum : Health-Care Professional
Desirable : Physician with PhD (Dr. med.; MD, PhD)
Pharmaceutical industry experience with 10-12 years of relevant experience
Why consider Novartis?
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.
Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.