Join Lifelancer as a Senior Pharmacovigilance Reporting Associate (Remote)

 

Join Lifelancer as a Senior Pharmacovigilance Reporting Associate (Remote)

Position Name: Senior Pharmacovigilance Reporting Associate

Organization: Lifelancer

Qualification: Not specified

Experience: Mid-Senior level

Salary: Not disclosed

Location: Remote (Full-time)

At Lifelancer, we are committed to delivering high-quality pharmacovigilance services. Our team works closely with clients to ensure compliance and accuracy in safety reporting. Join us and be a part of a dynamic team that makes a difference in the healthcare industry.

Job Description

THE POSITION:

This position involves various responsibilities in the submission and oversight of safety reports and intelligence for clients, regulatory authorities, and other stakeholders.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Submission of Safety Reports: 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 within project-specified timelines.
• Release of Safety Reporting Intelligence: Release safety reporting intelligence for expedited and periodic reports, line listings, for regulatory authorities, ethics committees, and investigators within specified timelines.
• Understanding of Safety Reporting Systems: Maintain a comprehensive understanding of ICON's safety reporting systems, processes, and conventions.
• Compliance with SOPs and WPs: Maintain a comprehensive understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents, and manuals associated with safety reporting.
• Project Oversight: 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.
• Lead Capacity: Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.
• Completion of Project Activities: Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
• Support to Safety Reporting Group Management: Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight, and CAPA oversight.
• Collaboration: Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
• Database Management: Work within multiple databases and maintain project information or pharmacovigilance intelligence information with timely updates.
• Document Filing and Quality Control: Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness for audits or inspections.
• Audit and Inspection Preparation: Prepare for and represent the department in audits and inspections.
• Coaching and Mentoring: Effectively coach and mentor less experienced associates in all aspects of safety reporting or safety reporting intelligence.
• Routine Project Activities: Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders.
• Client and Internal Meetings: Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects.
• Therapeutic Area Understanding: Maintain understanding of applicable therapeutic areas and disease states.
• Travel: Travel (approximately 10%) domestic and/or international, as required.
• Other Activities: Perform other activities as identified and requested by management.

ABOUT LIFELANCER:

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.

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