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Pv Associate/Sr Pv Associate

0-2 years
Not Disclosed
10 Oct. 29, 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

Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We pride ourselves on fostering an inclusive environment that drives innovation and excellence. Join us on our mission to shape the future of clinical development.

Position Summary:
We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team in Chennai. In this role, you will be responsible for reviewing and processing safety events, generating data listings, and supporting safety management plans.

What You Will Be Doing:

  • Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs) according to assigned tasks and project-specific procedures.
  • Analyze abstracts and full articles to extract safety information for both pre and post-marketed products.
  • Generate data listings from the safety database, ensuring data accuracy.
  • Complete adverse event follow-ups via writing and/or phone, tailored to client requirements.
  • Maintain and review relevant safety tracking systems for accuracy and quality, assisting with project file maintenance.
  • Perform safety reviews of clinical and diagnostic data as part of case processing.
  • Develop and maintain the Safety Management Plan, ensuring project consistency.
  • Support post-marketing safety activities, including PSMF, RMP, and PBRER.
  • Liaise with investigational sites, reporters, and sponsors regarding safety issues.
  • Collaborate with ICON Medical Monitor, project managers, and other departments as needed.
  • Assist in identifying out-of-scope activities in collaboration with the Pharmacovigilance Project Lead.
  • Attend project team and Sponsor meetings, presenting safety processes as required.
  • Support the generation of aggregated safety reports, including Development Safety Update Reports and Periodic Safety Update Reports.
  • Maintain the safety database and ensure quality control of data entry.
  • Aid in the creation and reconciliation of SAE/AE plans.
  • Support signal detection and risk management activities.
  • Propose solutions for procedural and technical challenges.
  • Assist with audits and inspections as needed for assigned projects.
  • Respond to and process medical inquiries related to adverse events and product complaints.

Your Profile:

  • Experience in a pharmaceutical or CRO environment.
  • At least 1 year of experience in pharmacovigilance.
  • Excellent verbal and written communication skills.
  • Detail-oriented with strong organizational and time management abilities.
  • Fluent in written and verbal English.
  • Ability to work effectively both independently and as part of a team across global teams.

What ICON Can Offer You:
Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits designed for your well-being and work-life balance, including:

  • Various annual leave entitlements.
  • Comprehensive health insurance options for you and your family.
  • Competitive retirement planning offerings.
  • Global Employee Assistance Programme providing 24/7 support.
  • Life assurance and flexible country-specific optional benefits.

At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We are committed to providing an inclusive and accessible environment for all candidates. We welcome applications from individuals of all backgrounds, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you need reasonable accommodation during the application process due to a medical condition or disability, please let us know.

Interested in the role?
Even if you’re unsure if you meet all the requirements, we encourage you to apply! You might be exactly what we’re looking for, whether for this position or others at ICON.