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hace 2 meses
We are seeking a highly skilled Pharmacovigilance Reporting Associate to join our team at 520 Icr Mexico - Mex. As a key member of our Pharmacovigilance team, you will play a critical role in ensuring the safe and effective reporting of adverse events and other safety-related information to regulatory authorities and clients.
Key Responsibilities- Process and submit 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 within project specified timelines.
- Release safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines.
- 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.
- 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, building and maintaining good relationships across functional units.
- Work within multiple databases, maintaining 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.
- Effectively coach and mentor less experienced associates in all aspects of safety reporting or safety reporting intelligence and other work, as needed.
- Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned.
- Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects as designated.
- Maintain understanding of applicable therapeutic areas and disease states as required.
- Experience in Pharmaceutical/CRO environment
- At least 3 years of experience in the pharmacovigilance area
- Excellent verbal and written communication skills
- Detail-oriented
- Fluent in written and verbal English
- Excellent organizational and time management skills
- Ability to work effectively independently and within a team environment and across global teams
We are 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. Our people are our greatest strength, and we are committed to providing a workplace free of discrimination and harassment.
