Medical Safety Lead/sr
vor 15 Stunden
**Sourcing Statement**
766 million. That’s how many lives our products touch. 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?
**Senior Medical Safety Lead**
As our MSL, you will be in close collaboration with the Global Program Safety Lead (GPSL) providing robust safety evaluation expertise and medical innovation in order to improve patients’ lives and impact on overall Novartis results.
As a member of the Medical Safety organization, you prioritize the safety of patients, ensure optimal patient safety for assigned compounds and share responsibility for the integration, analysis, and evaluation of internal and external safety information through product lifecycle management. You may also deputize partial or full responsibilities of a GPSL.
**Your Responsibilities Include, but are not limited to**:
- Monitor the clinical safety of projects/products including activities such as literature review, evaluation of
individual cases or signal detection, and respond to safety-related questions appropriately. You may deputize for the GPSL (in agreement with the project’s GPSL) or function as a GPSL for products to which no GPSL are assigned.
- Perform medical assessment and related activities for single cases whenever required, 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. Of note: medical review of single case reports may need to be
performed by Senior Medical Safety Leads as required according to business needs.
- Identify safety signals based on the review of solicited or unsolicited single cases. Perform signal detection, monitoring and evaluation of all safety signals based on single cases and aggregate data using proper signal detection tools.
- Provide inputs into responses to inquiries from regulatory authorities or health care professionals on
safety issues. Prepare safety data for Health Authority review boards. Provide input to responses for legal queries and Country Organization requests involving safety issues.
- Provide pharmacovigilance inputs to initial development and subsequent updates of core data sheet (CDS) and its related documents. May review and author submission documents (e.g. summary of clinical safety, clinical overview).
- Play a significant role in the development and maintenance of Safety Profiling Plans (SPP) and Risk
Management Plans (RMP) including the coordination with other line functions for associated activities such as updates, and the ongoing tracking of commitments and effectiveness measures.
- Provide guidance as appropriate to Clinical/PV Safety Operations for the coding and causality/expectedness assessment of adverse event reports
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
**What you'll bring to the role**:
- Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field or Medical Degree (MBBS or MD) required.
- Medical degree with specialization preferred. Medical degree is essential for associates performing medical review of single case reports whenever business needs require this activity.
**Experience/Professional requirement**:
- Relevant experience (e.g., clinical, postdoctoral) after graduation
- At least 6 years in drug development in a major pharmaceutical company, including 4 years in patient safety at an operational or medical position (or
equivalent experience) is desirable.
- Experience in drug development, clinical trial methodology, regulatory requirements,
scientific methodology, statistics and writing of publications.
- Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.
- Experience in preparing or contributing to preparation of clinical safety assessments
- Experience with (safety or others) issue management
**Division**
Global Drug Development
**Business Unit**
CMO & PATIENT SAFETY GDD
**Country**
Switzerland
**Work Location**
Basel
**Company/Legal Entity**
Novartis Pharma AG
**Alternative Country 1**
USA
**Alternative Country 2**
Spain
**Alternative Country 3**
India
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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