Safety Case Expert

**Summary**: Provide support for medical safety management within the Patient Safety & Pharmacovigilance department, including medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co - authoring safety documents, assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority...

As a key member of our Pharmacovigilance team, you will play a crucial role in managing individual case safety reports. This includes performing initial case-level assessments to confirm the seriousness and expectedness of adverse events, composing accurate medical narratives, and generating queries for missing information.Responsibilities:Process daily...

Job Summary:A Senior Business Analyst is required to provide expert-level support to the development of business systems and processes. The ideal candidate will have a strong understanding of drug safety business processes, MedDRA, and disease dictionaries.Key Responsibilities:Collaborate with cross-functional teams to anticipate future needs and...

**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

As a Quality Assurance Associate, you will be responsible for ensuring the quality of case intake and processing activities conducted by vendors.This role involves vendor oversight, compliance with approved processes and training requirements, managing relationships with business partners, and supporting safety reporting to regulatory bodies.Key...

**Major accountabilities**: - Provide support according to the needs for delivery activities, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. - Assist the GPSL/MSL/MSE in monitoring the safety profile of products including with activities such as...

Job Title: Clinical Case SpecialistJob DescriptionYou will be accountable for ensuring the quality of Individual Case Safety Reports (ICSRs) globally. This role involves significant vendor oversight, ensuring compliance with approved processes and maintaining a state of inspection readiness.You will be a key point of contact for safety reporting and apply...

Senior Case Management SpecialistJob Overview:The Senior Case Management Specialist will support interactions with business partners and vendors for all case intake and processing activities.Key Responsibilities:Vendor oversight of all case intake and processing activities and case quality, including analysis and reporting of trends in quality...

Job OpportunityAt our organization, we empower biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs by providing expert advice and support throughout the product lifecycle.We partner with clients through a collaborative model that combines deep domain expertise in regulatory sciences, clinical research solutions, quality...

**Description** **Safety Physician** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...