Medical Safety Lead

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz

**Your Key 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).
- 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).
- Provides safety inputs for clinical and regulatory deliverables including but not limited to clinical study protocols (e.g. - PASS, consortia studies etc.), clinical study reports, investigator brochure and safety management plans.
- 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 Provides relevant inputs for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed depending upon the portfolio and products assigned.
- 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.
- Provide safety input for Post marketing surveillance plans, Clinical Evaluation Plan and
- Report (CEP/CER) and other safety related documents in the context of EU Medical Device Regulations.
- Preparation and review of working instructions and procedures.
- Perform tasks as per assigned workstreams.

**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.
- Medical degree with specialization preferred
- Medical degree is essential for associates performing medical review of single case reports whenever business needs require this activity.
- Fluent English knowledge in spoken and written
- 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,