Madrigalpharma
Senior Manager, Post-Marketing Pharmacovigilance
Madrigalpharma, Conshohocken, Pennsylvania, United States
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: Senior Manager, Post-Marketing Pharmacovigilance Reporting to the Associate Director, Post-Marketing Pharmacovigilance, the Senior Manager, Post Marketing Pharmacovigilance, will play a key role in safety assessment, evaluation and risk management of marketed products.
Position Responsibilities: Assist with oversight of pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety information. Perform retrospective and in-line quality checks (QC) to ensure proper coding and processing of post-marketing reports which includes tracking and trending for issues as well as remediation effectiveness. Create and utilize trackers to assist team in monitoring vendor KPIs. Provide review of ICSRs (including case narratives, causality assessments and coding) for assigned products. Ensure compliance with the required timelines for safety submissions globally. Assist management team with writing and reviewing safety procedural documents. Interface with outside partners and vendors for pharmacovigilance and patient safety related tasks. Assist with other PV compliance activities as required. Other duties as assigned. Qualifications 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 worldwide. Good knowledge of US and EU pharmacovigilance regulations. Experience in managing external vendors preferred. Excellent written and verbal communication skills. Excellent in detailed-oriented tasks. Experience with case processing, including MedDRA and WHO Drug coding and narrative writing. Experience with safety databases; Argus is a plus but not mandatory. Compensation: 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.
#J-18808-Ljbffr
Role Overview: Senior Manager, Post-Marketing Pharmacovigilance Reporting to the Associate Director, Post-Marketing Pharmacovigilance, the Senior Manager, Post Marketing Pharmacovigilance, will play a key role in safety assessment, evaluation and risk management of marketed products.
Position Responsibilities: Assist with oversight of pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety information. Perform retrospective and in-line quality checks (QC) to ensure proper coding and processing of post-marketing reports which includes tracking and trending for issues as well as remediation effectiveness. Create and utilize trackers to assist team in monitoring vendor KPIs. Provide review of ICSRs (including case narratives, causality assessments and coding) for assigned products. Ensure compliance with the required timelines for safety submissions globally. Assist management team with writing and reviewing safety procedural documents. Interface with outside partners and vendors for pharmacovigilance and patient safety related tasks. Assist with other PV compliance activities as required. Other duties as assigned. Qualifications 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 worldwide. Good knowledge of US and EU pharmacovigilance regulations. Experience in managing external vendors preferred. Excellent written and verbal communication skills. Excellent in detailed-oriented tasks. Experience with case processing, including MedDRA and WHO Drug coding and narrative writing. Experience with safety databases; Argus is a plus but not mandatory. Compensation: 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.
#J-18808-Ljbffr