Title: Global Case Management Specialist
Location: Remote
Reports to: Sr. Manager, PV Operations Global Case Management
The Global Case Management Specialist will be responsible for effective execution of the activities of triage, processing, and quality control of individual case safety reports (ICSR) from clinical trials to ensure timely and accurate assessment of adverse event reports. This role will focus on accurate case entry and writing a detailed narrative to describe adverse events reported in clinical trials. This is an exciting time to join as we experience acceleration in our pipeline and late phase development, thereby poising us for substantial growth in the upcoming years. The Specialist, Global Case Management will provide critical support to company's future success in making a transformative impact to patients through vaccines and therapeutics. This is an exciting opportunity to play an important and valued role as a member of the PV team at a high-growth organization that is radically changing the biotech industry and promoting global public health.
location: Cambridge, Massachusetts
job type: Contract
work hours: 9 to 5
education: Bachelors
responsibilities:
Here's What You'll Do:
- Perform activities of triage of ICSRs as needed
- Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments.
- Use source documents received to write a comprehensive narrative describing the adverse event appropriately.
- Process safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and Company requirements.
- Operate on Electronic Data Capture to perform follow-up with clinical trial sites.
- Manage multiple tasks simultaneously and prioritize competing requests and or projects
- Escalate issues as needed
- Assist with individual projects assigned by global PV management in support of Clinical Safety and Pharmacovigilance departmental initiatives
qualifications:
REQUIRED
- Bachelors/Associate degree preferably in life science, nursing, pharmacy or other healthcare related profession
- Minimum 2 years of experience in drug safety/pharmacovigilance case processing
- Medical Writing experience preferred
- Argus safety database and other platform experience (MS Office suite, Excel, PowerPoint, Visio, electronic data capture (EDC) systems, and electronic document management systems etc.)
- Knowledge of GCPs, ICH guidelines, and FDA, EMA, and other international regulations and guidelines
- Strong interpersonal and communication skills (verbal and writing); proactive approach. Able to work both independently and in a team environment
- Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously and independently
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, and the ability to successfully execute in an environment under time and resource pressures
- Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Fluency in English required
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
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 health, an incentive and recognition program, and 401K contribution (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.
