Pharmacovigilance Scientist (PV)

Mineralys Therapeutics is a publicly traded, clinical-stage biotechnology company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Our initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that we are developing for cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and chronic kidney disease. Mineralys is a fully remote company. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn. The Pharmacovigilance Scientist (PVS) is responsible for providing operational and scientific contributions to Drug Safety, Pharmacovigilance, and Risk Management activities related to the company's product portfolio. This role involves directly conducting safety activities, ensuring compliance with regulatory requirements, and supporting the preparation of safety reports and analyses. Key Responsibilities:

• Support the PV team in quality control review of individual case safety reports (ICSRs) to ensure accuracy, completeness, and regulatory compliance.
• Support the Identification and communication of discrepancies or trends in case processing and collaborate on corrective actions.
• Support and contribute to departmental SOPs and work instructions. Work closely with the Quality Assurance for the finalization of SOPs.
• Signal Detection and Management:
• Conduct regular signal detection activities using various data sources, including spontaneous reports, clinical trial data, and literature.
• Analyze data to identify potential safety signals and trends.
• Evaluate the clinical significance of identified signals and recommend appropriate actions.
• Prepare and present signal detection reports to safety committees and regulatory authorities.
• Maintain and update signal management plans and documentation.
• Coordinate and participate in Safety Management Team meetings and clinical study-level Safety Review Committee meetings.
• Coordinate and participate in Safety Management Team meetings and clinical study-level Safety Review Committee meetings.
• Contribute to the preparation of safety documentation for NDA submissions, including Integrated Summary of Safety (ISS), Summary of Clinical Safety and Risk Management Plan (RMP)
• Assist and contribute to safety sections of the Investigators Brochure and DSUR
• Assist in preparing and reviewing safety sections of clinical documents and responses to regulatory agency questions.
• Support audits and inspections related to pharmacovigilance activities.
• Maintain up-to-date knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).

Qualifications

• Bachelor’s Degree in biologic or natural science, or health case discipline; or Advanced degree preferable (DDS, DMD, BDS, PhD, MPH, NP, PharmD, etc.) required.
• Minimum of 3 years of Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.

Required Skills

• Strong organizational skills, including the ability to prioritize independently with minimal supervision.
• Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.
• Strong knowledge of common data processing software and database systems such as Argus
• Expertise in safety data analysis and signal management. Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format
• Strong understanding of US and EU pharmacovigilance regulatory requirements.
• Ability to deliver high-quality reports and innovative solutions for aggregate safety
• Knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
• Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
• Applies clinical judgment to interpret case information.

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