Medical Safety Lead Jobs at Novartis Pharma Company. Interested Candidate Can Apply For This Position
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IMPORTANT INFORMATION |
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Employer Novartis Location Holzkirchen (near Munich), Germany Salary Competitive Position Type Full Time Organization Type Pharma Closing date 29 May 2023 |
Job Description Medical Safety Lead
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz... are you ready to make a difference?
Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Owning the safety strategy of the assigned products andensures 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).
• Monitoringandevaluationofallsafetysignals both from internal and external sourcesincluding literature sources,singlecases and/oraggregatedataand presents the assessment to the Sandoz Safety Management Team/ Governance Board / other internal/external boards as needed.
• Lead/Review the authoring of pharmacovigilance cumulative reviews/clinical overviews/HA responses to support initial submissions and updates of the company core data sheet (cCDS)/ Safety labels.
• Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, and other related departments (including but not limited toclinicalstudyprotocols, clinicalstudy reports,investigator brochure andsafety management plans).
• Provides support as needed for regulatory authority inspections and internal/external audits. Perform Root cause analysis (RCA) and propose robust Corrective and Preventive Actions (CAPA) as appropriate.
• Provides support as needed for licensing activities. Leads the safety review for due diligences/mergers and acquisitions and proposes relevant action/mitigation strategies.
• Preparation and review of working instructions and procedures.
• Perform tasks as per assigned workstreams.
Diversity & Inclusion / EEO
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:
Essential 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.
• Fluent in spoken and written English.
• Relevant experience (e.g., clinical, postdoctoral) after graduation.
• 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.
Desirable Requirements:
• Medical degree with specialization preferred.
• 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.
• Understanding in another major language (e.g., French, German, and Spanish) preferred.
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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