Job Description

Summary Responsible for all activities related to the Global Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature. ICSR Case Processing, including but not limited to case receipt and registration, triage, data entry, quality control, and report review/submissions.

Our Pharmaceutical Diagnostics (PDX) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDX products support three patients every second around the world.



Essential Responsibilities

Receive, register, triage and process adverse event and medical device reports from all sources including post-marketing, clinical trials and published literature

Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines

Perform data entry and quality review of adverse event reports into the global safety database, including accurate coding of MedDRA terms and preparation of case narratives

Identify missing or discrepant information and perform active case follow-up via verbal or written contact

Prepare expedited reports for submission to regulatory authorities and ethics committees

Serve as pharmacovigilance liaison and resource to internal and external groups (e.g., regulatory affairs, medical affairs, clinical development teams, CROs, etc.) on issues related to pharmacovigilance

Interface with quality assurance on product quality issues

• Perform reconciliations between clinical, quality and PV databases

Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed

Support preparation and submission of aggregate reports including PSURs, DSURs, and US Periodic Reports, as needed

Serve as pharmacovigilance resource during inspections and audits

Qualifications/Requirements

BS (Life Sciences Background) or equivalent with minimum of 3 years of pharmaceutical/biotechnology PV case processing experience, including clinical trial and postmarketing experience. Global experience preferred.

Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review and follow-up

Proficient in data entry and electronic reporting in global drug safety databases

Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines

Understanding of Microsoft office applications, specifically Excel and Word

Desired Characteristics

Healthcare professional (Nurse or Pharmacist) with clinical experience preferred

Experience with Argus preferred

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information

Relocation Assistance Provided: No