Performs pharmacovigilance activities for assigned Novartis projects or products including identification and analysis of safety signals based on a comprehensive evaluation of post-marketing data and Serious Adverse Events (SAEs) from clinical trials. May function as a Brand Safety Leader (BSL) for products in which no BSL is assigned.
1. Monitors the clinical safety of assigned product/projects potentially including activities such as literature review, evaluation of individual cases or signal detection. Medical review of single case reports will be performed by associates possessing medical degree
2. Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, literature review and preparation of investigator notifications and periodic medical assessments for ethics committees
3. Identifies safety signals based on the review of solicited or unsolicited single cases
Performs signal triage and signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools
4. Provides input into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues
5. Provides pharmacovigilance input to initial development of core data sheet (CDS) and its related documents. May author safety clinical overview
6. Plays significant role in the development and maintenance of RMPs including the coordination with other line functions for associated activities such as updates, and the ongoing tracking of commitments and effectiveness measures
7. Provides guidance as appropriate to Clinical Safety Operations for the coding and causality/expectedness assessment of adverse event reports
8. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments
9. Provides safety input for clinical and regulatory deliverables including clinical study protocols, clinical study reports, investigator brochure, submission documents
10. Provides relevant input for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and CTT meetings as needed
11. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities
12. May function as a BSL for products/compounds in which no BSL is assigned
13. May deputize for BSL for more complex compounds including SMT chair
Key Performance Indicators:
1. Timeliness and quality of safety analyses, interpretations, and presentations
2. Compliance with internal and external regulations and procedures.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Education (minimum/desirable): Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/ PhD in relevant field or Medical Degree/(MBBS or MD) required, with specialization preferred.
Medical degree is essential for associates performing medical review of single case reports.
Languages: Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) preferred.
Postdoctoral experience (after medical school graduation).
At least 4 years in drug development in a major pharmaceutical company including 2 years in drug safety at an operational or medical position.
Proven ability to analyze, interpret, discuss, and represent safety information both in writing and orally.
Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information.
Experience with (safety or others) issue management.
Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.
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