Senior Manager - Pharmacovigilance

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

As the Senior Manager – Pharmacovigilance, you will be responsible for overseeing a large team of PV professionals, for an assigned FSP client program in APAC. Reporting into the Director of Medical Safety Services, this is a critical role in supporting the further development of the fully embedded team. There will also be further scope to support and lead other teams within the business. You will also have the opportunity to play a key role in department initiatives and to advance your management skills as part of the Pharmacovigilance FSP leadership team

• Manages personnel within Pharmacovigilance and has expertise with regards to the tasks of the subordinated group (E.g. may provide services for Serious Adverse Events (SAE)/Adverse Reactions /Medical Device Report management, periodic safety reports, adjudication, coding, product complaints).
• Monitors projects to assure company profitability and associated project goals and objectives are being met
• Develops, implements, and monitors profitability, objectives and metrics of assigned group of direct reports.
• Supports departmental initiatives and development of SOPs, investigation of process related issues, consulting on safety processes, tools, and regulatory compliance.
• May serve as the main point of contact for the customer for the life-cycle of assigned stand-alone safety and medical information projects, and the main pharmacovigilance point of contact for assigned projects
• Provides technical oversight of the generation of project plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans, in close cooperation with project team during set-up phase
• Liaises with other functional managers to ensure consistency of pharmacovigilance approaches within the company
• Reviews Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager group-related project tasks; provides leadership in the delivery of related services to clients.
• Supports direct reports in identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required
• Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.

You possess

• Bachelor’s degree (or higher) in a healthcare-related or life science field
• A minimum of 8 years’ experience at a senior level within Pharmacovigilance within a CRO or BPO
• Broad knowledge of clinical development and / or safety requirements from pre-clinical to post marketing.
• Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team
• Excellent Project Management skills
• Analytical mindset
• Fluency in Japanese would be an advantage

Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.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, 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.