About Madrigal:
Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Role Overview:
The Manager, Clinical Safety & Medical Operations will play a key role in supporting the safety assessment, evaluation and risk management of products in various stages of development as well as involvement in safety surveillance activities.
Position Responsibilities: Review ICSRs (including case narratives, causality assessments and coding) for assigned projectsAssist with oversight of clinical pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety information. Oversee monthly reconciliation process performed by PV vendorReview eCRF data listings, as assigned, for inconsistencies and provide draft queries to appropriate team membersAssist with data collection for development of safety content for relevant safety documentsReview relevant study documents for safety-related information for assigned projects (e.g. Protocols, Safety Management Plan, SAE Reconciliation Plan, CRF, etc.)Support aggregate report deliverables, such as writing and review of regulatory safety documents for assigned projects, e.g., Development Safety Update Reports (DSURs), Mexico annual report.Interface with outside partners and vendors for clinical pharmacovigilance around patient safety related tasksAssist with Adjudication Committee activities including case identification, tracking, collection of appropriate data/records for submission to adjudication databaseAssist with Data Monitoring Committee activities, as neededAssist with other PV compliance activities as requiredOther duties as assignedQualifications and Skills Required: Bachelor's degree in relevant scientific discipline. Clinical experience (e.g. RN, BSN, or PharmD) is preferred, but not required.Drug Safety professional with a minimum of 5 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwideAbility to interpret health and medical records such as adverse event reporting forms, discharge summaries, etc.Experience with safety databases; Argus is a plus but not mandatoryExperience with EDC for clinical trial data collectionExperience with clinical case processing, including MedDRA and WHO Drug coding and narrative writingGood knowledge of pharmacovigilance reporting rules and timelinesGood knowledge of ICH E2B(R2) and (R3) specifications and entry guidanceExperience in managing external teams preferredExcellent written and verbal communication skillsExcellent in detail-oriented tasksCompensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
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