Senior Pharmacovigilance Associate

KCR Placement; Warszawa; Hybride; PLN 180 000 - 240 000; Plein temps

Résumé du poste

ICON Strategic Solutions in Warsaw seeks a Senior Pharmacovigilance Associate to lead pharmacovigilance and drug safety deliverables in a sponsor-dedicated, hybrid role. You will manage adverse event reporting, data interpretation, and regulatory submissions, contributing to patient safety and regulatory compliance.

You will work with cross-functional teams to assess clinical relevance, mentor junior staff, and support audits and inspections, while maintaining PV databases and ensuring data

Qualifications

• Bachelor's degree in a scientific/healthcare field.
• Extensive pharmacovigilance or drug safety experience.
• Strong knowledge of regulations and industry standards.

Responsabilités

• Lead collection, evaluation and processing of adverse event reports per regulatory guidelines.
• Analyze safety data, identify trends and potential signals requiring investigation.
• Prepare and submit PSURs and other regulatory documents with compliance.
• Collaborate with medical/clinical teams on assessing clinical relevance of events.
• Maintain PV databases with accurate documentation and data management standards.
• Provide training and mentorship on PV processes and regulatory requirements.

Connaissances

Pharmacovigilance

Regulatory knowledge

Data analysis

Adverse event reporting

Mentorship

English fluency

Polish fluency

Communication

Formation

Bachelor's degree in life sciences

Outils

PV databases

MS Office

Description du poste

Senior Pharmacovigilance Associate, Hybrid, Warsaw

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and oversee pharmacovigilance activities.

What You Will Do:

You will take ownership of pharmacovigilance and drug safety deliverables, applying your expertise to complex challenges.
Key responsibilities include:

• Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
• Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.
• Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.
• Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
• Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
• Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
• Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.

Your Profile:

You will have a strong foundation in pharmacovigilance and drug safety, with the experience to work independently and guide others.
Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.
• Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.
• Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations.
• Fluency in both English and Polish (written and spoken).
• Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
• Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply