Pharmacovigilance Associates/senior Associates

hace 3 semanas

Iztapalapa, México Icon plc A tiempo completo

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center 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.

We are looking for Associates and Senior Associates for the Pharmacovigilance Safety & Reporting group

Responsibilities (Safety):

- Perform processing for all types of safety events, medical information call handling activities and other medically related project information.
- Perform reconciliation of SAEs, literature surveillance, and data retrievals from the safety database. Supports the generation of aggregated safety reports, and Data Monitoring Committees (DMC) reviews.
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information.
- Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.

For ICON Strategic Solutions, may also include:

- Serve as safety reporting or safety reporting intelligence processor and/or lead for multiple safety reporting or safety reporting intelligence stand-alone projects, providing management support as designated.
- Responsible for safety reporting or safety reporting intelligence activities on assigned projects, working in a customer focused approach and an audit and inspection ready mindset.
- Demonstrate skills pertaining to client management, safety reporting, project scope, submission compliance, quality, and budget.
- Coding Adverse Events in accordance to the applicable standard dictionary
- Serve as quality complaint processor for assigned projects and monitor the process of returning samples for quality compliant and applicable tracking
- Complete adverse event and/or product quality complaint cases follow-up in writing and/or by phone based on requirements for each Client.
- Perform periodic reconciliation of adverse event and/or quality complaint cases received from different sources within the required deadlines

Responsibilities (Reporting):

- 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, if required & as agreed with client during study set-up, 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.
- Maintain a strong understanding of ICON's safety reporting systems, processes, and conventions, as appropriate.
- Maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.
- Perform oversight of assigned projects 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 Pharmacovigilance 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 for audits or inspections.
- Prepare for and represent the department in audits and inspections as designated.
- Review regulatory and safety reporting intelligence to keep updated on current regulations, practices, procedures,

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