Description
As a Senior Pharmacovigilance Associate at ICON Strategic Solutions in Warsaw, you will play a key role in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities.
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.
To be successful in this role, you will have:
- A 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.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:
- Competitive base salary and performance-related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways