Deputy EU-QPPV and Head Medical Safety International

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 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.'

Title: Deputy EU-QPPV and Head Medical Safety International

Location: The Netherlands, Amsterdam

Job Description

• Designated deputy EU-QPPV for all marketing authorizations held in the EU/EEA collaborating with the EU-QPPV to ensure full Compliance with EU GVP and contact for EMA and EU national regulatory authorities in the case of absence oft he EU-QPPV

• Drive oversight and maintenance of the PSMF (Pharmacovigilance System Master File) in compliance with regulatory requirements

• Responsibility for the elements of the Pharmacovigilance System (ICSRs, SOPs, PSURs, RMPs, PASS protocols, risk minimization strategies, effectiveness of follow-up measures, post marketing commitments to EMA and individual member states, safety database and submission as well as resolution of CAPAs from audits and inspections.

• Lead and oversee the management of safety profiles for all Madrigal products authorized in the EU in a collaborative way and ensuring high quality safety documents and responses to regulatory authorities.

• Responsible for Signal Management and Risk Management activities of Madrigal and ensuring QPPV authority on effective evaluation and communication of any safety concerns to relevant authorities.

• Ensuring appropriate pharmaco-epidemiology expertise is provided to the evaluation of safety concerns or response to regulatory authorities

• Responsible for continuous monitoring of safety profiles of Madrigal medicinal products

• Ensures the organization keeps up to date with relevant regulations, legislation and literature review of PV and Pharmacoepidemiology.

• Accountable for supervision and guidance of PV activities outsourced to third parties and distributors.

• Ensures stable information flow and good collaboration with R&D, Clinical & PV Quality assurance and other stakeholders

Key Requirements:

• Deep understanding of Pharmacovigilance requirements in the EU and globally

• Ability to lead the organization to built a global PV system

• Remains calm in situations of high pressure

Competencies:

• Agile and pragmatic approach, but adhering to regulatory boundaries
• Natural Leadership attitude, also ability to lead non-direct reports

• Solution oriented

• Good negotiator

• Innovation mindset

Education:

• Medical degree required due to regulatory requirement, background in Pharmacoepidemiology is a benefit

Experience:

• Minimum 15y experience in global PV organisation, at least 10y in PV Leadership position

Additional Information

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.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.