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 Pharmacovigilance team at ICON you will play a vital role in providing administrative support on global projects.   Your attention to detail will be essential in supporting the organization’s commitment to patient safety and compliance.  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:

•    Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes;
•    Provide administrative support to project teams as required;
•    Distribute safety reports to Sponsors, sites, and applicable ICON personnel in accordance with  Standard Operating Procedures and Project Specific Procedures ;
•    Coordinate setup of required systems and mailboxes during study startup (mailboxes, distribution lists, shared drives, tracking tools, etc.);
•    File all documents within allotted timeframes, including maintenance of project mailboxes and maintenance of TMF and E-TMF, including performing quality control checks;
•    Maintain data entry for safety event and miscellaneous tracking logs for all current projects;
•    Assist with organization and planning of meetings (room planning, set-up, and attendee logistics), including preparation and distribution of presentations, agendas, and meeting minutes, as requested;
•    Daily entry into, and maintenance of, appropriate tracking systems (e.g. SAE/safety event tracking systems);
•    Maintain project training records for all assigned project team members;
•    Handle Safety Reporting courier submissions to Competent Authorities and Ethics Committees and acknowledges receipt in Safety Reporting System;
•    Updating and maintenance of project database information systems;
•    Perform regular testing of fax numbers and e-mail addresses as required;
•    Maintenance, coordination and updates of shared and validated documentation repositories;
•    Coordination of translation of documents for projects
•    Completion of monthly metrics;
•    Handling requests for literature and articles;
•    Assistance with audit schedules and arrangement, including preparation of documents;
•    Assist with generation/distribution of project specific procedures;
•    Support QPPV, including PSMF activities as required;
•    Attend project team and Sponsor meetings and teleconferences as required;
•    Able to lead and mentor other team members (more Senior Admin roles).
 

Your Profile:

•    Bachelor’s degree in life sciences, pharmacy, or a related field or equivalent experience in an administrative role (any industry);
•     Pharma/CRO experience is not a necessity although basic understanding of pharmacovigilance principles and regulatory requirements is advantageous but not essential (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;
•    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;
•    Excellent computer skills (Microsoft Word, Excel, Outlook, PowerPoint);
•    Fluent in written and verbal English;
•    Ability to work effectively independently and within a team environment and across global teams.

#LI-Hybrid

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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