Senior Pharmacovigilance Reporting Associate

Sr PV Reporting Associate - Office with Hybrid - Sofia, Bulgaria (OK)

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 Senior Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Reporting Associate at ICON, you will be essential in ensuring accurate and timely reporting of safety data related to pharmaceutical products. You will work closely with cross-functional teams to enhance the organization’s pharmacovigilance reporting processes and maintain compliance with regulatory standards.

The role is Office Hybrid in Sofia, Bulgaria: 60% office based/40% remote.

What You Will Be Doing:

•  Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects. Perform oversight of assigned projects and collaborate closely with clinical and regulatory teams, ensuring all ICON, Sponsor, and regulatory timeframes are met.
•  Prepare and submitting expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel as applicable and in compliance with reporting obligations.
•  Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
•  Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated.
•  Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable and build and maintain good relationships across functional units.
•  Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases.
•  Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections.
•  Prepare for and represent the department in audits and inspections as designated.
•  Effectively coaches, trains, and mentors less experienced associates in all aspects of safety reporting or safety reporting intelligence and other work, as needed.
•  Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned.
•  Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects as designated. 

Your Profile: 

•    You are an HCP or have a life sciences degree.
•    At least 3-6 years of experience in Pharmacovigilance.
•    Knowledge of GCP and regulatory requirements.
•    CRO experience and experience with safety regulatory reporting is a plus.
•    Have an extensive experience in pharmacovigilance and drug safety reporting, with a strong understanding of relevant regulations and guidelines. 
•    Project lead experience is a plus.
•    Proven ability to prepare and submit accurate adverse event reports and safety data in a timely manner.
•    Strong analytical and PV operational skills, with the ability to interpret safety data and identify trends or issues requiring further action.
•    Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
•    Proficiency in pharmacovigilance databases and reporting tools, as well as Microsoft Office Suite.
•    Ability to manage multiple projects and priorities in a fast-paced environment while maintaining attention to detail.
 

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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