Pharmacovigilance Assistant II

Jobtailor; Warszawa; On-site; PLN 60,000 - 100,000; Full time

Job summary

Jobtailor is seeking a Pharmacovigilance Specialist to oversee adverse event reporting and data integrity. You will ensure compliance with regulatory requirements, review safety data, and support periodic safety reports for submissions and sponsors.

You'll collaborate with cross-functional teams and external partners to resolve safety-data queries and maintain audit-ready PV documentation in a fast-paced environment.

Qualifications

• Bachelor's degree in life sciences, pharmacy, or a related field.
• Previous experience in pharmacovigilance or drug safety.
• Regulatory requirements and safety reporting processes.
• Attention to detail and organizational skills.
• Ability to manage complex data sets and reports.
• Strong communication and teamwork skills.
• Experience collaborating across cross-functional teams and external partners.
• Ability to work in a fast-paced environment.
• Ability to ensure compliance with regulatory guidelines and timelines.
• Legal right to work in the country where the role is based.

Responsibilities

• Oversee the collection, processing, and timely reporting of adverse event reports in compliance with regulatory requirements.
• Ensure accurate data entry and maintenance of pharmacovigilance databases.
• Review reports for consistency and completeness.
• Assist in preparing periodic safety reports, including risk-benefit analyses, for regulatory submissions and sponsors.
• Collaborate with internal teams and external stakeholders to resolve safety-data and pharmacovigilance queries.
• Support audit and inspection readiness by maintaining comprehensive documentation of pharmacovigilance activities and safety reports.

Skills

Pharmacovigilance

Regulatory Compliance

Data Management

Safety Reporting

Cross-Functional Collaboration

Education

Bachelor's degree in life sciences

Tools

Pharmacovigilance Databases

Job description

• Oversee the collection, processing, and timely reporting of adverse event reports in compliance with regulatory requirements
• Ensure accurate data entry and maintenance of pharmacovigilance databases
• Review reports for consistency and completeness
• Assist in preparing periodic safety reports, including risk-benefit analyses, for regulatory submissions and sponsors
• Collaborate with internal teams and external stakeholders to resolve safety-data and pharmacovigilance queries
• Support audit and inspection readiness by maintaining comprehensive documentation of pharmacovigilance activities and safety reports

Requirements

• Bachelor's degree in life sciences, pharmacy, or a related field
• Previous experience in pharmacovigilance or drug safety
• Solid understanding of regulatory requirements and safety reporting processes
• Excellent attention to detail and strong organizational skills
• Ability to manage complex data sets and reports
• Strong communication and teamwork skills
• Experience collaborating across cross-functional teams and external partners
• Ability to work in a fast-paced environment
• Ability to ensure compliance with regulatory guidelines and timelines
• Legal right to work in the country where the role is based

Core Competencies

Demonstrates expertise in pharmacovigilance and drug safety, ensuring compliance with regulatory requirements while managing complex data sets and reports. Strong collaboration and communication skills are essential for working with cross-functional teams and external stakeholders.

Highest-signal resume keywords

• Pharmacovigilance
• Regulatory Compliance
• Data Management
• Safety Reporting
• Cross-Functional Collaboration

ATS Optimization Keywords

Hard Skills

• Data Entry
• Pharmacovigilance Databases
• Risk-Benefit Analysis
• Adverse Event Reporting
• Safety Data Review

Soft Skills

• Attention to Detail
• Organizational Skills
• Communication Skills
• Teamwork Skills

Industry Keywords

• Life Sciences
• Drug Safety
• Regulatory Requirements
• Safety Reports
• Audit Readiness