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Pv Associate/Sr Pv Associate

0-2 years
Not Disclosed
10 April 17, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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: PV Associate/Sr PV Associate
Location: Chennai
Job Code: JR127208
Department: Drug Safety
Company: ICON plc (Full Service & Corporate Support Office Based)


Job Overview:

ICON plc is a leading healthcare intelligence and clinical research organization, dedicated to shaping the future of clinical development. They are seeking a Pharmacovigilance (PV) Associate/Sr PV Associate to support pharmacovigilance activities for both pre-marketing and post-marketing drug safety processes.

Key Responsibilities:

  • Review and process safety events (adverse events) for various product stages (pre-marketing, post-marketing, medical device).

  • Conduct safety literature reviews to identify safety information from scientific abstracts and full articles.

  • Maintain safety database and ensure accuracy of data listings.

  • Perform adverse event follow-ups, communicate with reporters, investigational sites, and sponsors.

  • Develop and review safety management plans and safety tracking systems.

  • Generate and support the creation of safety reports and regulatory submissions (e.g., PSMF, RMP, PBRER).

  • Perform signal detection and risk management activities.

  • Support the Qualified Person for Pharmacovigilance (QP) and assist in audits and inspections.

  • Attend project team and sponsor meetings, providing input on safety processes.

What You Will Be Doing:

  • Collect and review adverse event reports in compliance with regulatory guidelines.

  • Collaborate with cross-functional teams to support safety investigations.

  • Stay updated on pharmacovigilance regulations and best practices.

  • Assist in preparing safety reports for regulatory submissions.

Required Qualifications:

  • Education: Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred.

  • Experience: Experience in pharmacovigilance, drug safety, or clinical/pharmaceutical environment.

  • Skills: Strong analytical skills, attention to detail, excellent communication, and interpersonal skills.

What ICON Offers:

  • Competitive salary with benefits including health insurance, retirement plans, and wellness programs.

  • Global Employee Assistance Program offering 24/7 support.

  • Flexible and family-friendly benefits, such as annual leave and childcare vouchers.

Company Culture & Values:

  • ICON fosters an inclusive and diverse culture.

  • Commitment to providing an accessible and discrimination-free workplace.

  • Equal consideration for all qualified applicants, regardless of background.

How to Apply:

Interested candidates are encouraged to apply, even if they don’t meet all the listed requirements. ICON is open to a diverse range of candidates for this and other roles.