Pharmacovigilance Scientist (PV)

Mineralys Therapeutics; Poland; Remote; PLN 50,000 - 70,000; Full time

Job summary

A biotechnology company in Poland is seeking a Pharmacovigilance Specialist to support quality control and analysis of safety reports. The ideal candidate will have a Bachelor's degree in a relevant field, a minimum of 3 years of experience, and expertise in signal management. Responsibilities include analyzing data for safety signals, preparing documentation for regulatory submissions, and maintaining compliance with pharmacovigilance regulations.

Qualifications

• Minimum of 3 years of Pharmacovigilance experience.
• Strong knowledge of global PV regulations.
• Excellent analytical, communication, and organizational skills.

Responsibilities

• Support quality control review of individual case safety reports.
• Analyze data to identify potential safety signals.
• Prepare and present signal detection reports to regulatory authorities.

Skills

Safety data analysis

Signal management

Regulatory submissions

Analytical skills

Communication skills

Organizational skills

Education

Bachelor’s Degree in biologic or natural science

Advanced degree (e.g., DDS, PhD)

Tools

Microsoft Office Suite

Argus safety database

Job description

Overview

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.

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.
• Support 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.
• 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 care discipline; or Advanced degree preferred (e.g., DDS, DMD, BDS, PhD, MPH, NP, PharmD) with at least a required level of experience.
• Minimum of 3 years of Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
• Strong knowledge of global PV regulations and safety databases (Argus).
• Excellent analytical, communication, and organizational skills.
• Proficiency in Microsoft Office Suite and safety data management tools.

Required Skills

• 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.
• Prior experience with regulatory submissions and audits.
• 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.
• Strong understanding of US and EU pharmacovigilance regulatory requirements.