Medical Safety Lead Vacancy @ Novartis – B Pharma/D Pharma
Dont forget to check out possible interview questions for this job below
Novartis hiring Novartis invites candidates bachelor’s and diploma degree in pharmacy for the post of medical safety lead. Pharmacy job opening 2023, M Pharma job opening 2023, B Pharma job opening 2023, Pharmacy job opening 2023, Intrested and eligible canoddates may check out all the details on the same below:
Job Title: Medical Safety Lead (Sandoz)
Job Id: 365030BR
Minimum requirements
• Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Masters 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.
• Relevant experience (e.g., clinical, postdoctoral) after graduation.
• At least 4 years in drug development in a major pharmaceutical company, including 2 years in patient safety at an operational or medical position (or equivalent experience) is desirable.
• 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 and regulatory reports involving safety information• Experience with (safety or others) issue management and decision making on safety topics.
Job Description
2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role.
Your responsibilities include, but are not limited to:
• Owns the safety strategy of the assigned products and ensures ongoing evaluation of the overall safety profile, serving as the medical safety representative for Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Annual Product Quality Reports (APQRs) and medical risk assessments (MRAs).
• Preparation/review of investigator notifications and periodic medical assessments for ethics committees. Medical review of single case reports according to business needs (example SUSARs)
• Review safety documents prepared by External Service Providers. Performs medical assessment of product quality defects with or without adverse events, including the review of line listings whenever required and proposes relevant market action.
• Monitoring and evaluation of all safety signals both from internal and external sources including literature sources, single cases and/or aggregate data and presents the assessment to the Sandoz Safety Management Team/ Governance Board / other internal/external boards as needed.
• Prepares safety responses to inquiries from regulatory authorities, health care professionals or legal queries on the benefit-risk balance of assigned products. Supports Country Organization and other stakeholders on safety related questions when global input is required.
• Depending on assigned products and portfolio, may support the GPSL/Medical Safety Group Lead and the Senior Medical Safety Lead in submission activities as required by providing pharmacovigilance inputs to initial development and updates of core data sheet (CDS) and its related documents. In this context, the Medical Safety Lead may deputize for the Senior Medical Safety Lead for the preparation of safety documents (e.g. summary of clinical safety, clinical overview) for review by GPSL.
• Lead/Review the authoring of pharmacovigilance cumulative reviews/clinical overviews to support initial submissions and updates of the company core data sheet (cCDS)/ Safety labels.
• Provides guidance as appropriate to Case processing team for the coding and causality/expectedness assessment of adverse event reports as and when needed. Provides inputs and collaborates on preparation of Safety Profiling Plan (SPP)
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Important Interview Questions and Answers for the above job role:
- Can you tell us about your experience in drug development and patient safety?
Answer: I have at least 4 years of experience in drug development in a major pharmaceutical company, including 2 years in patient safety at an operational or medical position. I have worked on a variety of safety-related tasks, including the preparation of clinical safety assessments and regulatory reports.
2. How do you ensure ongoing evaluation of the overall safety profile of assigned products?
Answer: I own the safety strategy of the assigned products and monitor and evaluate all safety signals from internal and external sources, including literature sources, single cases, and aggregate data. I also prepare safety responses to inquiries from regulatory authorities, healthcare professionals, or legal queries on the benefit-risk balance of assigned products.
3. Can you give an example of how you have contributed to issue management and decision making on safety topics?
Answer: I have contributed to issue management and decision making on safety topics by performing medical assessments of product quality defects with or without adverse events, proposing relevant market action, and presenting the assessment to the Sandoz Safety Management Team/ Governance Board / other internal/external boards as needed.
4. How do you ensure compliance with regulatory requirements related to safety documentation and reporting?
Answer: I ensure compliance with regulatory requirements related to safety documentation and reporting by preparing or contributing to the preparation of clinical safety assessments and regulatory reports involving safety information. I also support the Senior Medical Safety Lead in submission activities as required by providing pharmacovigilance inputs to initial development and updates of core data sheet (CDS) and its related documents.
5. How do you collaborate with other stakeholders, such as case processing teams and country organizations, on safety-related questions and tasks?
Answer: I provide guidance as appropriate to case processing teams for the coding and causality/expectedness assessment of adverse event reports as and when needed. I also support country organizations and other stakeholders on safety-related questions when global input is required. In addition, depending on assigned products and portfolio, I may lead/review the authoring of pharmacovigilance cumulative reviews/clinical overviews to support initial submissions and updates of the company core data sheet (cCDS)/Safety labels.
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