QPPV Support Specialist

Are you passionate about ensuring patient safety and advancing pharmacovigilance excellence?

At Zentiva, we are looking for a QPPV Support Specialist to work directly with our EU Lead of QPPV, PV Policy and Compliance (Qualified Person Pharmacovigilance, Pharmacovigilance Policy and Compliance) and support the QPPV office’s operations, maintaining robust pharmacovigilance systems to ensure accurate documentation across our processes.

This position offers an exciting opportunity to grow your career in an international matrix environment while making a tangible impact on regulatory compliance and patient safety.

You will have the opportunity to:

• Support the QPPV office activities - Change control process, Affiliates oversight, Internal Meetings Coordination
• Maintain Pharmacovigilance documentation - Regular PSMF updates, Continuous Management of Source Data, Participation in creation and update of Operational Standards
• Pharmacovigilance Regulatory Intelligence - Monitor pharmacovigilance legislation, Track and Communicate to relevant stakeholders.
• Support Audits and Inspections - Support the QPPV team in audit and inspection readiness by ensuring documentation is complete, organized, and up to date.
• Manage Deviations and CAPA - Assist in deviation management and implement corrective and preventive actions (CAPAs) following audits or inspections, Record and update data in QMS database
• Do Market Research and Patient Support Projects - Ensure pharmacovigilance obligations in market research programs and patient support projects, Communicate with service providers, other Zentiva departments and local pharmacovigilance teams

To thrive in this role you will need:

• DEGREE - Pharmaceutical University Degree (Chemical or Life Science degrees also acceptable)
• KNOWLEDGE of Pharmacovigilance Legislation and Regulation (including GVP, ICH guidelines). Previous experience in PV or QA is preferred
• SYSTEMS – MS Office savviness required, QMS tools savviness preferred (e.g. Trackwise, eDMS Lifescience, drugTrack)
• LANGUAGES – Fluent English is a must & Czech/Slovak - advantage
• ABILITIES & SKILLS - Ability to work in a multifunctional matrix organization, excellent eye for detail, collaboration skills

We promise you will own your success. We will empower you with the freedom and autonomy to shape your work, make key decisions, and take ownership of your success. We will trust you to lead, innovate, and make an impact from day one.

Our Recruitment Process:

To be considered for this role, please apply in our Applicant tracking system and refrain from sending your CV via email. Upon the completion of sourcing (CV collection) period, all received application will be reviewed by our Recruitment experts and evaluated against the needs of the open role. Successful candidates will be contacted by our Recruiting experts for an initial screening interview during which further details about the selection process will be shared. Successful candidates will progress to interviews with line managers, while not selected candidates will be informed in a written form as soon as possible. 

Diversity is a fact. Inclusion is an act @Zentiva

At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. To learn more about our D&I commitment, click here.

Join our winning team! Be part of our winning culture! Be Zentiva!