Global Program Safety Lead
Global Program Safety Lead
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$ 204400 - 379600
1 Vacancy
Job Description
Band
Level 6Job Description Summary
Designs & develops safety surveillance strategy for products and approval. Responsible for the companys drug surveillance program including the necessary follow-up risk assessment and relatedness to product on adverse reaction reports oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products life cycle. Provides safety support to the clinical development teams.Job Description
#LI-Hybrid
Two roles available
Key Responsibilities:
- 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) -Is responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
- 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.
- Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities.
- 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 -Contributes to and often leads the development of departmental and functional/business unit goals and objectives.
- Distribution of marketing samples (where applicable)
Key Performance Indicators:
- Timeliness and quality of safety analyses interpretations and presentations -Compliance with internal and external regulations & procedures -Compliance consistency and quality of safety deliverables
Essential Requirements:
- Medical Degree or equivalent (preferred) PhD PharmD orequivalent graduate level health care professional degreerequired. Specialty Board certification desirable. Useful additional degrees: Post graduate degree inPharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
- 5 years clinical experience postdoctoral
- At least 5 years progressive experience in drug development in a major pharmaceutical company including 3 years in safety at a medical position
- Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information to include NDA submission documents
- Strong experience in leading cross-functional multicultural teams
- Strong experience with (safety or others) issue management
- Strong experience in drug development clinical trialmethodology regulatory requirements scientific methodology statistics and writing of publication
- Strong leadership skills including coaching motivatingand directing and fostering teamwork. Ability to develop and maintain effective working relationships with subordinates superiors and peers
The salary for this position is expected to range between $204400 and $379600 per year.
The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Clinical Research Clinical Trials Functional Teams Leadership Medical Strategy Process Safety Management Regulatory Compliance Risk Management Safety ScienceRequired Experience:
Exec
Employment Type
Full-Time
