Senior Pharmacovigilance Associate
ICON plc
- Praca zdalna
Senior Pharmacovigilance Associate
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.
As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and oversee pharmacovigilance activities.
What You Will Do:
You will take ownership of pharmacovigilance and drug safety deliverables, applying your expertise to complex challenges.
Key responsibilities include:Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
Perform case processing for serious adverse events, serious and non-serious adverse drug reactions, and other medically- related project information, such as adverse events of special interest, clinical endpoints and medical information inquiries, literature surveillance, and data retrievals from the safety database.
Serve as Functional Lead on case processing projects as assigned; coordinates teams of Pharmacovigilance associates on project level and serves as the Pharmacovigilance point of contact for project teams.
Liaise with other ICON departments, investigational site, reporter, and/or Sponsor as necessary regarding safety issues
Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
Reports project status (including monthly metrics) to project/functional management within agreed upon timelines.
Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.
Effectively coaches and mentors less experienced Pharmacovigilance associates.
Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.
Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.
Your Profile:
You will have a strong foundation in pharmacovigilance and drug safety, with the experience to work independently and guide others.
Required qualifications and experience:Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.
Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.
Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations.
Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.
Ability to work independently and manage multiple priorities in a fast-paced environment.
#LI-SB2
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, 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