Data Integrity and Compliance Manager
2 days ago
We are looking for a highly skilled Safety Data Management Specialist to join our Clinical Trial Patient Safety team at AbbVie. In this role, you will be responsible for managing safety data for later-stage products, working closely with cross-functional teams to identify and communicate potential safety concerns.
The ideal candidate will have experience in drug/device safety, clinical trial life cycle management, and proficiency in specific databases such as oracle/clinical, PIMS, and laboratory databases. Strong analytical and problem-solving skills, as well as excellent communication and leadership abilities, are essential for success in this role.
Key Responsibilities:
- Manage safety data for later-stage products, ensuring accurate and timely reporting
- Collaborate with cross-functional teams to identify and communicate potential safety concerns
- Proactively utilize clinical experience and medical knowledge to support review of potential safety concerns from clinical trial data
Requirements:
- Bachelor's degree with related health science background; RN or clinical pharmacy experience preferred
- At least 6 years' experience in clinical practice and drug/device safety, including clinical trial life cycle management
- Proficiency in computer skills (Windows, Word, Excel) and specific databases
- Expertise in industry regulations, processes, and clinical safety
Benefits:
- A competitive salary of $103,500 - $197,000 per year, depending on location and experience
- A comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k)
- Eligibility to participate in short-term and long-term incentive programs
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