Pharmacovigilance Assistant (all levels)

Pharmacovigilance Assistant (all levels) - Hybrid in Sofia, Bulgaria

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Pharmacovigilance Assistant I/II/Senior to join our diverse and dynamic team. As part of the PV team at ICON you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. You will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.

The role is Hybrid in Sofia, Bulgaria - office-based 60%, home-based 40%.

What You Will Be Doing:

• Supporting the collection, review, and processing of adverse event reports related to clinical trials and marketed products.
• Ensuring timely and accurate data entry of safety information into pharmacovigilance databases.
• Assisting in the preparation and submission of safety reports to regulatory authorities and sponsors, as required.
• Collaborating with cross-functional teams to maintain compliance with safety regulations and company protocols.
• Maintaining detailed records and documentation related to pharmacovigilance activities and safety reporting.
• Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.
• Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.
   

Your Profile:

• Bachelor’s degree in life sciences, pharmacy, or a related field.
• Basic understanding of pharmacovigilance principles and regulatory requirements is preferred (for PV Assistant I) / Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment (for more senior levels).
• Strong attention to detail and organizational skills, with the ability to manage multiple tasks efficiently.
• Strong analytical skills with attention to detail in data collection and reporting.
• Effective communication and collaboration skills, with a focus on maintaining accuracy in documentation and reporting.
• Ability to work in a fast-paced, regulated environment, ensuring compliance with safety guidelines and protocols.

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, 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