Manager, Pharmacovigilance

Pharmacovigilance Manager - Office based (60%) - Bulgaria or Poland

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.

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

We are currently seeking a Pharmacovigilance Manager, Safety Reporting to join our diverse and dynamic team. As a Pharmacovigilance Manager at ICON, you will play a pivotal role in overseeing safety reporting processes, ensuring compliance with regulatory requirements, and safeguarding patient safety through the monitoring and evaluation of adverse events in clinical trials.

What you will be doing

• Oversee and manage the safety reporting process for clinical trials, ensuring timely and accurate submission of safety data to regulatory authorities.
• Line management of initially approximately 5 PV professionals in various global locations, which will grow over time and the team is built up to capacity.
• Collaborate with cross-functional teams to develop and implement safety management plans and ensure consistent adherence to global regulatory standards.
• Analyze and interpret adverse event data, identifying trends, and providing strategic insights to mitigate risks.
• Lead safety review meetings, contributing to the assessment and classification of safety signals and events.
• Provide training and guidance to internal teams and external partners on safety reporting procedures and regulatory requirements.

Your profile

• A degree in life sciences, pharmacy, or a related field; advanced degree preferred.
• Previous experience of line managing a team, preferably in various global locations.
• Strong experience with interviewing and assessing PV candidates during periods of team growth.
• Extensive experience in pharmacovigilance, particularly in safety reporting within a clinical trial setting.
• Strong knowledge of global regulatory requirements for safety reporting (e.g., FDA, EMA, ICH guidelines).•
• Previous experience of working through a period of harmonization and restructure post- Merger or acquisition would be an asset.
  Excellent analytical skills with the ability to interpret complex medical data and present findings clearly.
• Proven leadership abilities with experience in managing teams and collaborating with cross-functional stakeholders.

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

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and 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 through the form below.

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.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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