Drug Safety Case Processor

Planet Pharma is seeking a Drug Safety Case Processor to work for a clinical trials company in Switzerland.

You will be integral in ensuring the accurate and compliant management of adverse event (AE) reports. Working in a collaborative team environment, the role requires meticulous attention to detail and adherence to global regulations, Standard Operating Procedures (SOPs), and guidelines.

Key Responsibilities:

• Manage end-to-end processing of AE reports, including triaging, data entry, coding, narrative drafting, quality review, and submission of expedited reports to health authorities.
• Prioritize AE cases to meet regulatory timelines, as per established SOPs.
• Identify gaps in information and coordinate follow-up requests alongside the Drug Safety Physician.
• Monitor daily workflows and task lists to ensure timely and accurate case processing.
• Oversee reconciliation activities, ensuring data integrity and alignment with regulations.

Candidate Profile:

• Degree in life sciences (e.g., pharmacy, nursing) or equivalent qualification in a health-related field.
• At least 5 years of experience in safety or clinical data management.
• Solid understanding of medical terminology and disease processes.
• Strong proficiency in coding thesauri and medical/drug dictionaries.
• Comprehensive knowledge of EU and US safety reporting requirements.
• Excellent organizational skills, problem-solving abilities, and interpersonal skills, with a proven ability to perform under pressure and meet tight deadlines.
• Fluent in English, both written and spoken.