Biomapas is looking for a QPO (QPPV Office) Specialist to support our Pharmacovigilance operations and ensure regulatory compliance. You will contribute to our contractual partners' full Pharmacovigilance and Quality systems, managing safety information and processes within an international environment.
What You'll Do
- Contribute to the Customer’s full Pharmacovigilance and Quality system or parts of it.
- Perform intake, data entry, quality control, documentation, reporting, and exchange for safety reports.
- Support the maintenance, updating, and validation of the global Safety Database.
- Ensure weekly monitoring of international literature reviews.
- Establish and perform regular reconciliation of safety information with Biomapas contractual partners.
- Deliver pharmacovigilance trainings to Biomapas and partner personnel as required.
- Supervise local handling, preparation, and submission of Periodic Safety Update Reports, Risk Management Plans, and risk minimization activities.
- Ensure continuous safety profile monitoring and signal detection/evaluation.
- Participate in related inspections and audits, providing post-inspection support.
What We're Looking For
- University degree in the Life Science field.
- At least 2-year experience in Pharmacovigilance and expert knowledge of pharmacovigilance legislation.
- Knowledge of international regulations (ICH, EU GVP Modules, FDA).
- Experience working with PV databases.
- Strong computer literacy.
- Ability to interpret and apply global drug safety regulations.
- Fluent English language.
- Eagerness to adopt automations and new technologies in daily tasks.
- Attention to detail, time-management, and problem-solving skills.
Nice to Have
- Medical Information experience.
Team & Environment
You will support the QPPV Office and Pharmacovigilance department, working within an international team.
Benefits & Compensation
- Professional growth and career opportunities.
- International team and environment.
- Bonus based on annual performance.
- Personal accident and business trip insurance.
- Additional health insurance.
- Influenza vaccines.
- Rewarding referral policy.
- Workplace establishment allowance.
- Team building, global meetings, and B active events.
Work Mode
This is a fully remote, home-based position open to candidates in any European Union country.
Biomapas is an equal opportunity employer.
