Pharmaceutical Safety and Operations Director

2 weeks ago


Conshohocken, Pennsylvania, United States Madrigal Pharmaceuticals Corporation Full time

Madrigal Pharmaceuticals Corporation is seeking a highly skilled Clinical Safety and Medical Operations Manager to join their team.

About Us

We are a biopharmaceutical company focused on developing novel therapeutics for non-alcoholic steatohepatitis (NASH) and metabolic dysfunction associated steatohepatitis (MASH).

Our first therapy, Rezdiffra (resmetirom), has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for adults with NASH and moderate to advanced liver fibrosis.

The selected candidate will play a key role in supporting the safety assessment, evaluation, and risk management of our products in various stages of development.

Compensation Package

The base salary for this position is estimated to be around $130,000 per annum, depending on qualifications and experience.

The successful candidate may also be eligible for a bonus and equity package as well as comprehensive benefits, including flexible paid time off, medical, dental, vision, and life insurance.

Job Description
  • Review and assess ICSRs, case narratives, causality assessments, and coding for assigned projects.
  • Assist with oversight of clinical pharmacovigilance vendor activities, including assessment, evaluation, tracking, and reconciliation of safety information.
  • Review eCRF data listings for inconsistencies and provide draft queries to relevant team members.
  • Assist with data collection for safety content in relevant documents.
  • Review study documents for safety-related information.
  • Support aggregate report deliverables, such as writing and review of regulatory safety documents.
  • Interface with outside partners and vendors for clinical pharmacovigilance tasks.
  • Assist with Adjudication Committee activities and Data Monitoring Committee activities as needed.
Required Skills and Qualifications
  • Bachelor's degree in a relevant scientific discipline.
  • Minimum 5 years of experience in drug safety and pharmacovigilance, preferably with case quality control and regulatory submissions of ICSRs worldwide.
  • Ability to interpret health and medical records.
  • Experience with safety databases and EDC for clinical trial data collection.
  • Excellent written and verbal communication skills.


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