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Global Program Safety Lead (Gpsl)

Expired Job

Novartis Pharmaceuticals Cambridge , MA 02138

Posted 4 months ago

Job Description:

Successfully serves as scientific safety leader of the Medical Safety organization to

improve patients' lives and impact on overall Novartis results through robust safety

evaluation expertise and medical innovation. Ensures optimal patient safety for assigned

compounds, is responsible for the integration, analysis, and interpretation of internal and

external safety information from all sources through lifecycle management

Provides expert safety input to the clinical development program for assigned

projects/products and be an active member of the Global Program Team (GPT), Global

Clinical Team (GCT) and Clinical Trial Team (CTT).
2.Is responsible for safety issue management from formation of Global Program Team

(GPT) through Life Cycle Management.
3.Develops and is responsible for key internal Novartis safety documents: reviews these

documents regularly and updates as required (e.g. when significant new information

received). Ensures that these, and all other project-related safety documents, are

consistent in safety messages.
4.Owns the safety strategy and document it in the corresponding documents (e.g. dSPP,

SSPT) and leads the production of the medical safety deliverables (e.g. DSUR, PSUR,

RMP) for the assigned products.
5.Is responsible for overall signal detection, monitoring, evaluation, interpretation and

appropriate management of safety information, based on information from all relevant

line functions, post-marketing data, and other sources. To this end, constitutes and runs

the Safety Management Team (SMT). Ensures that this team appropriately and timely

reviews all medical safety data from various sources (e.g. pre-clinical, clinical trial data

post-marketing, literature) throughout the development and post-approval process.
6.Responsible for documentation/tracking/record keeping of the assigned compounds

medical safety activities.
7.Is responsible for initial development and ongoing maintenance of safety information in

Core Data Sheet (core global labeling), including addressing safety issues optimally

in all project/product labeling indications.
8.Is responsible for responses to inquiries from regulatory authorities or health care

professionals on safety issues. Leads the preparation of the safety strategy for health

authority responses and strategy, in collaboration with other project team members.

GPSL_Version 5

Prepares safety data for health authority review boards (together with the clinical and

biostatistical functions). Attends Health Authority Meetings in person, as required.
9.Is responsible for responses to legal queries and Country Organization (CO) requests

involving safety issues. Provides integrated safety input into all regulatory documents

required during active development.
10. Ensures safety information is communicated/escalated to HPS/MPH, HMS HYD and/or

EU Qualified Person in a timely fashion.
11. Facilitates involvement of external experts (e.g. authors of white papers, members of

trial- specific data safety monitoring boards, ad-hoc support for HA meetings, etc.).
12. Prepares and presents safety issues to internal Novartis Boards and other meetings as

required. Provides relevant input for SMT/SMB, GPT, GCT and CTT meetings as needed.
13. Initiates and maintains productive cross-functional Medical Safety collaborations with

colleagues within CMO&PS and those from other functions, e.g. Clinical Development

and Medical Affairs, Regulatory Affairs, Medical Information, Biostatistics, Quantitative

Safety & Epidemiology, Clinical Pharmacology, QA, BD&L and NIBR, as well as

externally with expert panels and other scientific contacts.
14. Provides expert medical input to trial and project level Drug Safety Monitoring

Board/Data Monitoring Committee and Safety Adjudication Committee activities for

assigned projects/products, as required.
15. Performs tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs), assigned

to the role.
16. Keeps working instructions / SOPs / GOPs for the area of responsibility up to date with

internal (e.g., QMs) and external (e.g., GVP modules) requirements, provides input to

such procedural documents of other functions, and ensures implementation of such

procedural documents in the area of responsibility.
17. Provides support as needed for licensing activities, regulatory authority inspections and

for project /product recall activities.
18. Leads the day-to-day safety activities and provides guidance to junior personnel.

Proactively engages in the development of competencies across the Medical Safety


Employment Type


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Global Program Safety Lead (Gpsl)

Expired Job

Novartis Pharmaceuticals