Supporting ongoing safety evaluation and pharmacovigilance activities for all products, the full-time Associate Director, Pharmacovigilance Scientist will manage serious adverse event reviews, author safety documents, and implement signal management processes in a remote work environment. Key responsibilities Perform sponsor review and approval of serious adverse event (SAE) and individual case safety reports in Argus, ensuring completeness and accuracy Author safety topic reviews, aggregate safety analyses, and benefit-risk assessments to support regulatory submissions and clinical documents Collaborate with internal teams and vendors to enhance signal management processes and ensure compliance with pharmacovigilance regulations Required qualifications Advanced degree in health sciences or life sciences (e.g., PharmD, MSN/NP, MPH) preferred; Bachelor's degree with significant relevant experience may be considered Typically 8 or more years of relevant experience in pharmacovigilance, clinical safety, or drug safety science within biotechnology or pharmaceutical settings Strong knowledge of global pharmacovigilance requirements, including ICH GCP and FDA safety reporting standards Hands-on experience with safety databases, preferably Argus, including case review and medical coding Demonstrated ability to synthesize complex clinical and safety data into clear, well-supported written assessments
...School Year! \n We're hiring now! Zen Educate is looking for Para Educators. If you're passionate about supporting students with special needs and want a role where you can make a real impact, this could be your next step. Nows your chance to get set up for success and...
...and customers and translating those needs into on-brand designs and templates. Highlights of your time with this Mortenson internship will include: ~ Building off existing social media templates to expand our library of assets~ Assisting in the creation of...
Job ID: 22123010Reference Number: 24-00358Title: CMS AnalystLocation: Iselin, NJ, 08830Posted Date: 2024-05-02Company: HAN StaffingCMS Analyst
...Job Description Job Description Landau Associates is recognized for excellence in the environmental consulting industry. With nine offices throughout the Pacific Northwest and Gulf Coast, our focus on collaboration, responsiveness, and quality results in client satisfaction...
...Description Superior Mechanical Services, Inc. provides mechanical and Plumbing services throughout the Maryland, Virginia and DC Metropolitan... .... These services include new construction, renovation and maintenance of HVAC and Plumbing systems for plan-spec, design-build and...