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Pv Associate/Sr Pv Associate

0-2 years
Not Disclosed
10 Oct. 30, 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 - Chennai, India

Company: ICON plc

About Us: 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 in shaping the future of clinical development!

Position Overview: We are seeking a dedicated Pharmacovigilance Associate to join our dynamic team. In this role, you will review and process safety events, conduct literature reviews, generate data listings, and support various pharmacovigilance activities.

Key Responsibilities:

  • Review and process safety events for pre-marketing, post-marketing, medical devices, and drugs.
  • Perform literature reviews to identify safety information for both pre and post-marketed products.
  • Generate data listings from the safety database, ensuring accuracy.
  • Complete adverse event follow-ups via written communication or phone.
  • Review safety tracking systems for accuracy and maintain project files.
  • Conduct safety reviews of clinical and diagnostic data during case processing.
  • Develop and support the Safety Management Plan, ensuring consistency within projects.
  • Assist in creating post-marketing safety activities such as PSMF, RMP, and PBRER.
  • Liaise with investigational sites, reporters, and Sponsors on safety issues.
  • Attend project team and Sponsor meetings, presenting safety processes as needed.
  • Support the generation of Aggregated Safety Reports and interim data analysis for DMC reviews.
  • Maintain the safety database, ensuring quality data entry and compliance with guidelines.
  • Respond to medical information inquiries regarding adverse events and product complaints.

Qualifications:

  • Experience in a Pharmaceutical/CRO environment.
  • At least 1 year of experience in pharmacovigilance.
  • Excellent verbal and written communication skills in English.
  • Detail-oriented with strong organizational and time management skills.
  • Ability to work independently and collaboratively within global teams.

What ICON Can Offer You: We believe our success depends on the quality of our people. Along with a competitive salary, ICON provides a comprehensive benefits package focused on well-being and work-life balance, including:

  • Various annual leave entitlements.
  • A range of health insurance options.
  • Competitive retirement planning offerings.
  • Global Employee Assistance Programme for 24-hour support.
  • Life assurance and flexible optional benefits.

To learn more about our benefits, visit our careers site.

Diversity and Inclusion: At ICON, diversity, inclusion, and belonging are integral to our culture. We are committed to providing an inclusive environment free from discrimination and harassment. All qualified applicants will receive equal consideration for employment.

If you require reasonable accommodations during the application process, please let us know or submit a request here.

Interested but Unsure? If you're interested in this role but don't meet all the requirements, we encourage you to apply—there's a chance you might be exactly what we're looking for!

Current ICON Employees: If you are a current ICON employee, please click here to apply.