This is a fantastic opportunity for a detail-oriented and experienced Information Specialist II to join a world-renowned leader in the healthcare space. You will play a critical remote role in ensuring the integrity and compliance of vital safety data by performing accurate registration and quality review of adverse event and product quality reports. The organization operates a large, dynamic site dedicated to discovering, developing, and providing innovative medicines globally. If you have superior attention to detail, strong data management experience, and thrive in a fast-paced environment, this is your chance to contribute significantly to global health and safety initiatives.
location: Telecommute
job type: Contract
salary: $24.00 - 27.11 per hour
work hours: 9 to 5
education: High School
responsibilities:
- Register and Process Reports: Accurately and timely register adverse event and product quality reports from initial receipt to data entry within required timeframes.
- Perform Quality Review: Conduct quality review of external provider's reconciliation tasks for both clinical and post-marketing cases (Medical Information, Product Complaints, and third-party vendor).
- Manage Data & Information: Maintain or manipulate large quantities of information, data, or documents in structured databases, filing systems, or associated reporting formats.
- Ensure Customer Service: Clearly and succinctly communicate information and demonstrate a high level of customer service to internal and external customers.
- Problem-Solve & Prioritize: Utilize rigorous logic to solve difficult problems and effectively prioritize and manage your own time to complete assigned tasks.
- Identify Improvements: Identify gaps and areas needing improvement, and communicate and/or implement recommendations or changes.
qualifications:
Required Skills & Experience:
Candidates must possess 3 to 5 years of experience or application/environment specific knowledge in pharmacovigilance, regulatory affairs, clinical data management, or a related medical/life science field to perform tasks where large quantities of adverse event, product quality, or other regulatory information, data, or documents need to be maintained or manipulated in a structured database, filing system, or associated reporting/holding format.
- Similar Work Experience: 6 months to 1 year of similar work experience (e.g., in data entry, safety case processing, or document control).
- Computer Proficiency: Excellent computer and keyboarding skills, including expertise in Excel, PowerPoint, Word, and Outlook (or equivalent email system).
- Database Familiarity: Prior experience and familiarity with computer databases (ideally those used for safety reporting).
- Attention to Detail: Superior attention to detail, quality, accuracy, and adherence to timelines.
- Time Management: Strong time management and prioritization skills; ability to multi-task and switch tasks to meet business needs.
- Communication & Service: Strong customer service skills and effective verbal and written communication.
- Work Style: Ability to work independently with minimal supervision as well as collaboratively and effectively within a team.
- Adaptability: Fast learner of technical and process skills/knowledge.
- Medical Terminology knowledge.
- Prior experience in a regulatory/medical/pharmaceutical setting (e.g., in a drug safety or medical information department).
skills: MS-EXCEL, Adverse Event (AE) Reporting, Case Processing
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
