Patient Safety Group Manager

Jun 16, 2021

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-
2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:
· Manage the Team of Patient Safety Coordinators, Patient Safety Specialists, Patient Safety
Associates and Patient Safety Managers*. Manage the Team in order to ensure appropriate
collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing surveillance (PMS), Spontaneous Reports (SR), registries, commercial programs, etc.
· Act as Qualified Delegate for Pharmacovigilance in Novartis Country Organization and manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk benefit, pharmacovigilance annual report) to Local Health Authorities (LHA) according to regulatory requirements. Acts as Patient Safety Country Head Deputy: *functional (in terms of responsibility for PV system) and operational (in terms of managing the PS Team).
· Maintains the oversight in order to ensure that reporting/submission/distribution of safety
reports/updates/information (e.g. SAE, SR, SUSAR, IN, PSUR, DSUR, changes in risk benefit, pharmacovigilance annual report) is done according to the timeliness described into the respective
· Work with other local/global PS and Medical Safety associates to ensure accurate evaluation of safety data. Interact and exchange relevant safety information with LHA, PS associates, other functional groups and third party contractor, if applicable. Survey and monitor national pharmacovigilance regulations and provide update to global PS organization. Set up, update and implement local procedures to ensure compliance with PS global procedures and national
· Coordinate execution of Risk Management Plans and ensure local PS-related RMP commitments are properly documented. Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Research Organization (CRO) is conducting the trial, review the contract (SSW).
· Acts as a key partner who provides input, during the process of establishing marketing program: comments on proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information. Ensure that relevant local literature articles are screened as appropriate. Supervision of management and maintenance all relevant PS databases. Ensure timely preparation and submission of KPI reports on AE reporting including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
· Support in developing and updating training materials for pharmacovigilance and ensure training of
Country Organization associates on relevant PS procedures for AE reporting, including field force and third party contractor, if applicable. Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
· Ensure training and oversight of staff, as applicable. Communicate and follow-up all
pharmacovigilance requests and keeping local management informed about relevant developments. Keeping good professional contacts with key Novartis personnel locally and globally. Select and recruit qualified PS associate. Other agreed tasks assigned by manager

Minimum Requirements

What you’ll bring to the job:
· Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent
education, training and experience
· Fluent in both written and spoken English. Good working knowledge of local language Knowledge of other languages desirable.
· At least 3 years experience in drug safety. OR at least 5 years experience as medical advisor or study manager.
· Excellent communications and negotiation skills. Leadership and management skills. Quality and focus oriented. Computer skills.

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Global Drug Development
Research & Development
Full Time
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Patient Safety Group Manager

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