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Pharmacovigilance Associate

0-2 years
Not Disclosed
10 Nov. 12, 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, 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

Job Title: Pharmacovigilance Associate

About the Role:
ICON plc is a world-leading healthcare intelligence and clinical research organization committed to shaping the future of clinical development. As a Pharmacovigilance Associate, you will be responsible for reviewing and processing safety events for pre-marketing, post-marketing, medical devices, and drugs. You will contribute to the creation and review of safety tracking systems, generate safety listings, and support post-marketing safety activities.

Key Responsibilities:

  • Safety Event Processing: Review and process safety events and medical information, including literature reviews and adverse event follow-up.
  • Data Management: Generate data listings from safety databases and ensure the accuracy of the data.
  • Safety Management: Develop Safety Management Plans and ensure consistency across project activities.
  • Regulatory Support: Assist in the creation of post-marketing safety activities such as PSMF, RMP, and PBRER.
  • Collaborative Liaison: Communicate with investigational sites, sponsors, and other stakeholders regarding safety issues.
  • Signal Detection & Risk Management: Support Safety Scientists in signal detection and risk management activities.
  • Aggregated Safety Reports: Assist in generating reports like DSUR, IND Annual Reports, and Periodic Safety Update Reports.
  • Quality Assurance: Maintain quality control processes in safety database entries and reconcile AE/SAE data as required.
  • Client Communication: Process medical inquiries related to adverse events and product complaints.

What ICON Can Offer You:
ICON offers a range of competitive benefits, including:

  • Various annual leave entitlements.
  • Health insurance tailored to you and your family's needs.
  • Retirement planning options for long-term financial security.
  • Global Employee Assistance Programme for 24/7 support.
  • Life assurance and flexible benefits (e.g., childcare, gym memberships).

Diversity and Inclusion:
ICON values diversity, inclusion, and belonging, fostering an environment where innovation thrives. We are committed to providing an inclusive and accessible workplace free from discrimination and harassment. All qualified applicants will be given equal consideration regardless of race, gender, or other protected statuses.