Senior Pharmacovigilance Reporting Associate

4+ years

Not Disclosed

Chennai

10 Aug. 8, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Role

At ICON, our people set us apart. Our diverse teams enable us to be a better partner to our customers and help us fulfill our mission to advance and improve patients' lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aim to be the Clinical Research Organization that delivers excellence to our clients and patients at every touchpoint. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll work in a dynamic and supportive environment with some of the brightest and friendliest people in the sector, helping shape an industry.

The Role:

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, within project-specified timelines.
Release safety reporting intelligence for expedited and periodic reports, and 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.
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 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.
Support 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.
Collaborate with 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. Maintain 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.
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 clients, authorities, and other stakeholders; review of project requirements and maintenance activities; review and escalation of metrics; and budget considerations as assigned.
Participate in client and internal meetings, representing the Safety Reporting department for assigned projects as designated.
Maintain understanding of applicable therapeutic areas and disease states as required.
Travel (approximately 10%) domestically and/or internationally, as required.
Perform other activities as identified and requested by management.

What We Are Looking For:

Bachelor’s or Master’s degree in Pharmacy or Pharmacovigilance.
4+ years of experience in Safety Submission & Regulatory submission.
Global exposure.
Cross-functional department exposure with team management experience.

Benefits of Working at ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer highly competitive salary packages. To keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect the delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans and related benefits such as life assurance so you can save and plan with confidence for the years ahead. Beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfill your sense of purpose and drive lasting change.

ICON 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, due to a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please let us know through the form below.

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Senior Pharmacovigilance Reporting Associate

Job Description

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