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Senior Pharmacovigilance Associate - United States (Remote or Hybrid)

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 have an incredible opportunity for a Senior Pharmacovigilance Associate to join ICON’s Full Service Post-Marketing and Medical Device Pharmacovigilance team. The Senior PV Associate will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities. They will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.

**Location:** United States (Remote or Office-Based Hybrid)

+ Blue Bell, PA

+ Raleigh, NC

What you will be doing:

+ Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies

+ Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation

+ Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations

+ Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities

+ 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

+ Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization

Your profile:

+ 3+ years of experience in pharmacovigilance or drug safety within a clinical or pharmaceutical environment

+ 3+ years of experience case processing and writing narratives in ARGUS or another safety database

+ Experience as a lead and interacting with the client

+ Strong analytical skills with attention to detail

+ Excellent communication and interpersonal skills, enabling effective collaboration with team members

+ A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities

+ Bachelor's degree in life sciences, pharmacy, or a related field

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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)

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 (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply