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Senior Pharmacovigilance Reporting Associate

2+ years
Not Disclosed
10 Jan. 13, 2025
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

Senior Pharmacovigilance Reporting Associate - CHN/BGLR - Office-Based

About ICON plc:

ICON plc is a leading global healthcare intelligence and clinical research organization dedicated to advancing the clinical development process. We are proud to create an inclusive environment that fosters innovation and excellence, and we invite you to be part of our mission to shape the future of clinical development.

At ICON, our people make the difference. By building diverse teams, we aim to enhance our partnership with clients and contribute to improving patient outcomes globally. Our commitment to our core values of Accountability & Delivery, Collaboration, Partnership, and Integrity drives us toward our goal of delivering excellence at every stage of the drug development process.

We are seeking driven, talented individuals who share our vision. Join our dynamic, supportive environment where you will collaborate with the brightest minds in the industry and help shape the future of healthcare.

Job Description:

As a Senior Pharmacovigilance Reporting Associate, you will play a key role in managing the submission and oversight of safety reports for our clinical trials. Your responsibilities will include:

  • Expedited Reporting: Ensure the timely submission of Serious Adverse Event (SAE) reports, periodic reports, line listings, and other applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, and third-party vendors.
  • Safety Reporting Intelligence: Manage the release of safety reporting intelligence for expedited and periodic reports in compliance with regulatory requirements and client expectations.
  • Oversight & Leadership: Oversee assigned projects to ensure adherence to ICON and regulatory timelines, ensuring high-quality safety reporting.
  • Collaboration & Support: Work closely with various stakeholders including project teams, clients, investigators, and vendors to maintain strong relationships and efficient reporting processes.
  • System and Procedure Expertise: Maintain knowledge of ICON’s safety reporting systems, Standard Operating Procedures (SOPs), and regulations related to pharmacovigilance.
  • Audit and Inspection Preparation: Participate in audits and inspections, ensuring the readiness of safety documentation and compliance with regulatory standards.
  • Training and Mentorship: Support the development of junior associates by providing guidance and training in pharmacovigilance activities.
  • Travel: Domestic and international travel may be required (approximately 10%).

What You’ll Bring:

  • Strong experience in pharmacovigilance and safety reporting, with a thorough understanding of global regulatory requirements.
  • Expertise in handling adverse event reporting, periodic safety reports, and safety intelligence across multiple projects.
  • Leadership skills to oversee project timelines and safety reporting activities, ensuring compliance with both ICON and client standards.
  • Ability to work collaboratively in cross-functional teams and maintain strong relationships with clients and other stakeholders.
  • Knowledge of pharmacovigilance databases and systems, and strong attention to detail for document filing and quality control.

Why Join ICON?

ICON’s success is driven by the quality of its people. We provide a competitive salary and benefits package, including:

  • Comprehensive Health Benefits: Tailored to suit you and your family’s needs.
  • Retirement Planning: Competitive retirement plans and life assurance to secure your future.
  • Work-Life Balance: Flexible country-specific benefits like childcare vouchers, subsidized gym memberships, travel passes, and more.
  • Employee Wellbeing: Access to global employee assistance programs, offering 24/7 support from a network of professionals.
  • Career Growth: A diverse, inclusive culture that fosters professional development and provides opportunities to make a lasting impact.

Commitment to Diversity & Inclusion:

ICON is an equal opportunity employer. We are dedicated to creating a workplace free of discrimination and harassment. We encourage individuals from all backgrounds to apply, and we provide reasonable accommodations for candidates with medical conditions or disabilities.

Interested in the Role?

If you’re passionate about pharmacovigilance and excited to make a difference in the clinical research industry, apply today. Don’t meet every requirement? We encourage you to apply anyway – you might be exactly what we’re looking for.

Current ICON Employees: If you are already part of the ICON team, please click here to apply.