Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests. Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary. Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications.
location: Telecommute
job type: Contract
salary: $40 - 45 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Collect, assess, and process adverse event information (both clinical and post-marketing) in a compliant and timely manner to adhere to global regulations. This includes:
- Seriousness assessment
- Labeling
- Causality determination
- Initial and follow-up evaluations
- Ensure adherence to company standards for quality, compliance, and productivity.
- Stay updated on the knowledge and skills required for effective case processing.
- This role is crucial for maintaining compliance with global regulatory standards and ensuring the highest quality of adverse event management.
qualifications:
Required Qualifications
- Minimum qualification: Bachelor's degree with a related health sciences background such as RN, BSN, BS, or BS Pharm. Candidates with previous pharmaceutical experience may also be considered even if they lack the appropriate degree.
- Required experience: 2-4 years of clinical experience, or 2-3 years of clinical experience combined with 1-year of Pharmacovigilance experience.
- Essential knowledge: Familiarity with industry regulations such as ICH, FDA, EMEA, and MHRA.
- Competency: Proficiency in case processing processes, procedures, and conventions
skills: Pharmacovigilance, ICH Regulations, Adverse Event (AE) Reporting, Case Processing, Good Pharmacovigilance Practices (GVP), Serious Adverse Event (SAE) Reporting, Food and Drug Administration (FDA), International Council for Harmonization (ICH)
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.
