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Pharmacovigilance Associates/Senior Associates

1+ years
Not Disclosed
10 Aug. 23, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Position: Pharmacovigilance Associate

Location: Mexico City, Mexico (Hybrid: Office/Remote)

Company Overview:

ICON plc is a leading global healthcare intelligence and clinical research organization. We are dedicated to fostering an inclusive environment that drives innovation and excellence in clinical development. Join us to contribute to shaping the future of healthcare.

Role Overview:

We are looking for a detail-oriented and motivated Pharmacovigilance Associate to join our dynamic team in Mexico City. In this role, you will be responsible for reviewing and processing safety events, supporting safety reporting activities, and ensuring high-quality data management.

Key Responsibilities:

  • Safety Event Management: Review and process safety events (pre-marketing, post-marketing, medical device, and drug) according to project-specific procedures.

  • Literature Review: Analyze abstracts and full articles to extract relevant safety information for both pre and post-marketed products.

  • Data Management: Generate data listings from safety databases, ensuring accuracy and integrity of the data.

  • Adverse Event Follow-Up: Conduct follow-up on adverse events in writing and/or by phone, in line with client requirements.

  • Safety Management Plans: Develop and maintain Safety Management Plans, ensuring consistency within projects and supporting post-marketing safety activities like PSMF, RMP, and PBRER.

  • Liaison Duties: Communicate with investigational sites, reporters, sponsors, and ICON team members to address safety issues and maintain effective working relationships.

  • Safety Reporting: Assist with the generation of aggregated safety reports, interim data analysis for Data Monitoring Committee reviews, and other safety-related documentation.

  • Database Maintenance: Maintain safety databases and entry guidelines, ensuring data quality and adherence to quality control processes.

  • Audit Support: Prepare for and support audits and inspections as required.

  • Medical Information Inquiries: Respond to and process medical information inquiries, including adverse events and product complaints.

Qualifications:

  • Experience: At least 1 year of experience in pharmacovigilance within a pharmaceutical or CRO environment.
  • Education: Bachelor’s degree in a healthcare-related or life science field preferred.
  • Skills: Excellent verbal and written communication skills, attention to detail, and strong organizational and time management abilities.
  • Languages: Fluent in English (both written and verbal).
  • Attributes: Ability to work independently and collaboratively within a global team.

What ICON Offers:

  • Competitive Salary: Attractive salary package with performance-based bonuses.
  • Health and Well-being: Comprehensive health insurance, life assurance, and global Employee Assistance Programme (LifeWorks).
  • Work-Life Balance: Flexible leave entitlements, retirement planning options, and various country-specific benefits.
  • Career Development: Opportunities for professional growth in a supportive and inclusive environment.

Equal Opportunity Employer:

ICON is committed to creating a diverse and inclusive workplace. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Accommodation Requests:

If you need a reasonable accommodation due to a medical condition or disability to perform the essential functions of this position, please let us know.

Interested?

If you are passionate about pharmacovigilance and meet the qualifications, we encourage you to apply. Even if you don’t meet all the requirements, we welcome your application.

Current ICON Employees:

Please click here to apply.

To explore more about our benefits and how you can make an impact at ICON, visit our careers site.