: 187656BR
Position Title: Brand Safety Leader
Division: PHARMA
Business Unit: Global Develop NPH
Country: India
: Hyderabad
: Nov Hltcr Shared Services Ind
: Research & Development
: Full Time
: Regular
Job Description:Serves as Global Program/Brand Team (GPT/GBT) scientific safety leader for assigned Novartis projects/products. Once the project team is formed, responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical through lifecycle management (post-approval) and externally.
1. Responsible for safety issue management from formation of GPT/GBT through Life Cycle Management (post-approval) 2. Develops and is responsible for key internal Novartis safety documents from the formation of the GPT/GBT through Life Cycle Management. 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 with one another 3. 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. Ensures that this team appropriately reviews all safety data from various sources (e.g. pre-clinical, clinical trial data presented by Clinical Trial Head (CTH) or Medical Scientific Expert (MSE), post-marketing, literature) throughout the development process 4. Provides expert safety input to the clinical development program for assigned projects/brands 5. Provides expert medical input to trial and project level Drug Safety Monitoring Board activities for assigned projects/products, as required, whilst remaining blinded 6. Responsible for initial development and updates of safety information in Basic Prescribing In- formation (core global labeling), including addressing safety issues optimally in all pro- ject/product labeling claims 7. Responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Responsible for re- sponses to legal queries and Country Pharma Organization (CPO) requests involving safety is- sues. Provides integrated safety input into all regulatory documents required during active development. Ensures safety information communicated to EU Qualified Person in a timely fashion 8. 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.) 9. Prepares and may present brand safety issues to internal Novartis Boards and other meetings 10. Provides relevant input for GPT/GBT, Global Clinical Team (GCT) and Clinical Trial Team (CTT) meetings as needed 11. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical
Candidate Profile
Medical Degree required. Specialty Board certification desirable. Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent) Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable
•3 years clinical experience postdoctoral
•At least 5 years are in drug development in a major pharmaceutical company (of which 2 years in a global position), including 2 years in safety at an operational or medical position
•Experience in preparing or contributing to preparation of clinical safety assessments and regulatory re- ports/submissions involving safety information
•Experience in leading cross-functional, multi-cultural teams
•Experience with (safety or others) issue management
•Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
1. Timeliness and quality of safety analyses, interpretations, and presentations2. Compliance with internal and external regulations and procedures
See All D.Pharm Alerts B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
.png)
