Product Safety Lead, Sandoz
vor 2 Wochen
The Product Safety Lead, Sandoz in close collaboration with Medical Safety Team Lead/the Global Program Safety Lead (GPSL) Biopharma/Head Patient Safety Biopharma and Generics provides robust safety evaluation expertise for assigned products in order to improve patients’ lives and impact on overall Novartis results. As a member of the Medical Safety organization, prioritizes the safety of patients, ensures optimal patient safety for assigned compounds and shares responsibility for the integration, analysis, and evaluation of internal and external safety information through product lifecycle management.
- Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives? Join Sandoz
- A division of Novartis, Sandoz is a global leader in Generic and Biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.**Your responsibilities**:
Your responsibilities include, but 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)
- 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
- Performs signal detection, 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 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
- Lead the authoring of pharmacovigilance cumulative reviews/clinical overviews to support initial submissions and updates of the company core data sheet (cCDS)/ Safety labels
- Ensures full compliance, quality and oversight of all RMP commitments
- Provides guidance as appropriate to Clinical and Pharmacovigilance Operations for the coding and causality/expectedness assessment of adverse event reports as and when needed
**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**:
- 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
- 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
**You’ll receive**:
Competitive salary; Performance based annual bonus; Work/life integration; Eligible to Sandoz pension plan; 30 working days' holiday per calendar year; Subsidised on-site cafeteria; Free shuttle bus between Sandoz and Holzkirchen train station; Additional benefits.**Why consider Sandoz?**
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
- The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
- Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.**Imagine what you could do at Sandoz**
**Commitment to Diversity & Inclusion**:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold
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