Pharmacovigilance SOPs & Training Associate, Sponsor Dedicated

ICON plc•Blue Bell, SD

About The Position

Manager, Pharmacovigilance SOPs & Training, Sponsor Dedicated 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 Manager, Pharmacovigilance to join our diverse and dynamic team. As a Manager, Pharmacovigilance at ICON, you will be responsible for overseeing the pharmacovigilance activities, ensuring the safety and efficacy of clinical trial products throughout their lifecycle. Your role will involve managing a dedicated team, ensuring compliance with regulatory requirements, and fostering a culture of safety and quality within the organization.

Requirements

Bachelor’s degree in life sciences, pharmacy, or a related field is preferred, with extensive experience in pharmacovigilance or drug safety management.
Proven experience in managing pharmacovigilance teams and activities, with a thorough understanding of regulatory requirements and safety reporting standards.
Strong analytical skills, with experience in assessing safety data and preparing safety reports for regulatory submission.
Excellent leadership and organizational skills, with the ability to manage multiple projects and deliver results in a fast-paced environment.
Exceptional communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
Detail-oriented, proactive, and committed to maintaining the highest standards of safety and quality in pharmacovigilance operations.

Responsibilities

Supports the development and implementation of training for Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, or other personnel within the assigned service area.
Recommends and supports implementation of performance and productivity improvements within the assigned service area to ensure optimal utilization of billable staff.
Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.
Identifies and implements process improvements through review of SOPs, processes; recommend improvement plans to senior management.
Participates in task forces to implement process improvement initiatives.
Builds teamwork and improves process and productivity by working within and across functional areas.
Develops company employees to ensure high quality work performance and retention of high quality employees.
Ensures staff development and performance feedback are provided through activities such as mentorship and career development.
Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities.
Involved in the recruiting processes for new employees in the assigned service area.

Benefits

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. 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 ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide.
You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.
If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.