Join a Top-Tier Leader as a Sr Associate, Case Management in this fully remote role. This position offers the flexibility to work from any US time zone while contributing to critical safety surveillance and pharmacovigilance operations. You will play a vital role in ensuring vendor compliance, managing ICSR quality, and maintaining accountability for FDA and EMA reporting.
location: Telecommute
job type: Contract
salary: $25.00 - 27.91 per hour
work hours: 9 to 5
education: High School
responsibilities:
- Perform comprehensive case reviews and ensure reporting compliance with strict global timelines and criteria.
- Oversee the quality of US Individual Case Safety Reports (ICSRs) for both clinical trials and post-marketing.
- Serve as the primary point of accountability for managing key vendor relationships and safety database activities.
- Facilitate E2B submission support and address case-related queries from internal business partners.
- Interface with CROs and local office staff to resolve complex case processing issues.
qualifications:
- Prior Pharmacovigilance experience or direct exposure
- Strong understanding of global regulatory requirements for pharmacovigilance
- Proficiency in safety database usage and medical coding
- Excellent English writing and professional phone communication skills
- Master's degree OR Bachelor's degree with 2 years of experience OR Associate's degree with 6 years of experience
- Note: Candidates with an MBBS or MD degree will not be considered
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 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.
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.
