Job Description
Major accountabilities:
- 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
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.
