Sr Associate, Case Management

job summary:

• To support the safety surveillance process for Company products by performing follow up activities with patients and HCPs of individual case safety reports.
• Ensure vendor compliance with approved processes and training requirements.
• Oversee case quality of US ICSRs (CT and PM) including analysis and reporting of trends in quality measures.
• Point of accountability for managing one or more key vendor relationships for ICSR processing.
• Case processing point of contact for case related activities with assigned business partners.
• Case processing point of contact for audit related activities related to case processing.
• Accountable for measuring quality against contractual safety agreements.
• Accountable FDA point of contact for ICSR reporting.
• Submission of all individual safety reports to FDA, EMA and Business Partners.

location: Telecommute
job type: Contract
salary: $25.00 - 27.91 per hour
work hours: 9 to 5
education: High School

responsibilities:

• Perform case review.
• Support the development and delivery of convention-related training material.
• Ensure compliance of reporting activities with timelines and criteria. Interface with local office staff, CROs and business partners for case processing issues as necessary.
• Provide E2B submission support (nullification, redistribution).
• Address case-related queries from Business Partners.
• Support antibody re-testing coordination (non-LAO tasks for repeat testing).

qualifications:

• Masters degree OR Bachelors degree and 2 years of [Job Codes Discipline and/or Sub-Discipline] experience OR Associates degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• Understanding of global regulatory requirements for pharmacovigilance.
• Familiarity with clinical development processes.
• Case processing experience.
• Attention to detail.
• Competence in safety database usage (preferably in Lifesphere Multivigilance by ArisGlobal) and medical coding.
• Comprehensive English writing skills.
• Excellent phone conversations skills.
• Comprehensive knowledge on MS Office applications.

skills: Pharmacovigilance, Case Processing, Individual Case Safety Report (ICSR), Good Pharmacovigilance Practices (GVP)


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 [email protected].


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.


Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.


Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.