Pharmacovigilance Manager
1 month ago
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.
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.
Key Responsibilities:- 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.
- 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.
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, annual bonuses, and a range of health-related benefits to employees and their families. We also provide competitive retirement plans and related benefits such as life assurance.
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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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