Pharmacovigilance Associates/Senior Associates

1+ years

Not Disclosed

Mexico

10 July 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Company: ICON plc
Location: Dublin, Ireland (Hybrid Work Environment)

ICON plc is a global leader in healthcare intelligence and clinical research, providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. We are dedicated to advancing clinical research and improving patient lives by accelerating the development of life-saving drugs and devices.

Our employees are the cornerstone of our success, fostering a culture driven by a mission to excel and a passion for high-quality work. We are currently seeking Associates and Senior Associates to join our Pharmacovigilance Safety & Reporting group.

Responsibilities (Safety):

Safety Event Processing: Handle all types of safety events, including medical information call handling and project-related medical information.
Reconciliation and Surveillance: Perform reconciliation of Serious Adverse Events (SAEs), literature surveillance, and data retrievals from the safety database. Support the generation of aggregated safety reports and Data Monitoring Committees (DMC) reviews.
Compliance: Ensure all ICON, Sponsor, and regulatory deadlines are met for processing and reporting safety information.
Departmental Support: Assist in the completion of departmental project activities according to ICON standards, regulatory requirements, and Sponsor agreements.
Safety Reporting: Serve as a processor or lead for safety reporting projects, managing multiple assignments and supporting client management, safety reporting, and compliance.
Quality Complaint Management: Process quality complaints for assigned projects and oversee the return of samples for quality complaints and applicable tracking.
Adverse Event Follow-up: Complete follow-ups on adverse event and product quality complaint cases as required by the client.

Responsibilities (Reporting):

Expedited and Periodic Reports: Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety information to clients, Regulatory Authorities, Ethics Committees, and other stakeholders within specified timelines.
Safety Reporting Intelligence: Release safety reporting intelligence for expedited and periodic reports, ensuring timely and accurate communication.
System Knowledge: Maintain a comprehensive understanding of ICON's safety reporting systems, processes, and conventions.
Regulatory Compliance: Ensure project activities comply with ICON standards, regulatory requirements, and client contractual obligations.
Leadership: Operate in a lead capacity for safety reporting activities, ensuring accountability and quality.
Audit Preparation: Prepare for and participate in audits and inspections, representing the Safety Reporting department.
Collaboration: Work closely with project team members, client contacts, investigators, and third-party vendors, building strong relationships.
Mentorship: Coach and mentor less experienced associates in safety reporting activities.
Project Coordination: Implement and coordinate routine project activities, including presentations, client responses, and budget considerations.
Therapeutic Area Knowledge: Maintain an understanding of relevant therapeutic areas and disease states.

Requirements:

Experience: At least 1 year of experience in pharmacovigilance within a pharmaceutical or CRO environment.
Communication: Excellent verbal and written communication skills in English.
Attention to Detail: Strong organizational and time management skills, with a detail-oriented approach.
Team Collaboration: Ability to work effectively both independently and within global teams.

Benefits of Working at ICON:

ICON values the contributions of its employees and offers competitive salary packages, including annual bonuses tied to performance goals. We provide a range of health-related benefits for employees and their families, competitive retirement plans, and related benefits such as life assurance. Beyond compensation, we foster an environment that encourages a sense of purpose and the drive to effect lasting change.

ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. We welcome all qualified applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you require a reasonable accommodation due to a medical condition or disability, please let us know through the form below.

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Pharmacovigilance Associates/Senior Associates

Job Description

About the Role

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