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Pharmacovigilance Reporting Specialist
1 month ago
About the Role:
We are seeking a highly skilled Pharmacovigilance Reporting Specialist to join our team at Pharmiweb. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the timely and accurate submission of safety reports to regulatory authorities, clients, and other stakeholders.
Key Responsibilities:
* Submission of expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and applicable safety information to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and ICON personnel, as required and agreed upon with the client, within project-specified timelines.
* Release of safety reporting intelligence for expedited and periodic reports, line listings, for regulatory authorities, ethics committees, and investigators within specified timelines in accordance with company procedures.
* Provide in-depth expertise regarding all aspects of safety reporting or safety reporting intelligence processes.
* Maintain a comprehensive understanding of ICON's safety reporting systems, processes, and conventions, as appropriate.
* Maintain a comprehensive understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents, and manuals associated with safety reporting.
* Provides technical and process oversight with respect to safety reporting services on assigned projects.
* Provides technical and process oversight with respect to safety reporting intelligence services on assignments.
* Perform oversight of assigned projects or portfolio ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements.
* Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.
* Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
* Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight, and CAPA oversight as designated.
* Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable. Build and maintain good relationships across functional units.
* Work within multiple databases. Maintenance of project information or safety reporting intelligence information with timely updates to the project or intelligence databases.
* Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects and safety reporting intelligence for audits or inspections.
Requirements:
* Bachelor's degree in life sciences
* 4 to 6 years of experience on a similar position in pharmacovigilance
* Fluency in English language
About 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 or submit a request here.
