What are the responsibilities and job description for the Director Pharmacovigilance Safety Systems position at Madrigal Pharmaceuticals?
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:
Director Pharmacovigilance Safety Systems
The focus for this position is to optimize global safety systems. This role will also be responsible for setting PV technology strategy, looking for opportunities for efficiency and innovation
Position Responsibilities:
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.
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.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
Powered by JazzHR
Hbr4GjA7E4
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:
Director Pharmacovigilance Safety Systems
The focus for this position is to optimize global safety systems. This role will also be responsible for setting PV technology strategy, looking for opportunities for efficiency and innovation
Position Responsibilities:
- Strategically lead PV systems management, ensuring alignment with global regulatory requirements
- System Management: Ensure the proper implementation, maintenance, and enhancement of pharmacovigilance systems and databases to support drug safety operations which also includes setting the outsourcing strategy with management approval
- Vendor Management: manage the identification and oversight of the safety system vendor including monitoring of Key Performance Indicators to ensure high-quality service and regulatory compliance
- Regulatory Compliance: Ensure all pharmacovigilance activities comply with global regulatory requirements, including FDA, EMA, and other relevant regulatory bodies. By ensuring safety system (e.g. Argus) is properly configured and validated to function as designed
- Data Analysis: Assist in the collection, analysis, and interpretation of safety data from various sources, ensuring accurate and timely reporting of adverse events by obtaining accurate outputs from the safety system
- Identify and drive continuous improvements in PV operations through innovative technology solutions, process enhancement and use of AI as appropriate
- Stakeholder Collaboration: Collaborate with internal and external stakeholders, including clinical development, regulatory affairs, and other internal departments, to ensure effective communication and coordination of safety information
- Education: Degree in computer science, Life Science or a related field
- Experience: Minimum of 10 years of experience in computer systems with at least 5 years in pharmacovigilance managing safety systems and operations
- Technical Skills: Expertise in pharmacovigilance safety databases (e.g. Argus, ARISg etc), safety reporting systems, and data analysis tools
- Regulatory Knowledge: In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH, FDA, and EMA requirements
- Analytical Skills: Strong analytical and problem-solving skills, with the ability to interpret complex safety data requests and make translate those to obtain necessary system outputs to allow safety decision making
- Communication Skills: Excellent written and verbal communication skills, with the ability to effectively communicate
- Experience managing vendor relationships and ensuring high-quality service delivery
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.
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.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
Powered by JazzHR
Hbr4GjA7E4
