- 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: $35.00 - 42.87 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (post marketing) is performed in a compliant and timely manner to comply with global regulations including:
- Seriousness assessment
- Labeling
- Causality
- Initial and Follow-up
- Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met. Remaining current on knowledge and skills required for case processing.
- Supporting vendor case quality, case processing metrics and agility using the Company core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One Company; Decide Smart and Sure.
- Supporting and participating in audits and inspections as needed.
- Developing knowledge and expertise to initiate mentoring of MSA's in vendor management.
- Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal Company trainings as needed.
- Other duties may be assigned based on the need or work requirement of the organization
qualifications:
- Nursing experience and preferably experience with critical care/ICU/Cardiac/ER. Pharmacovigilance experience preferred.
- Minimum: Bachelor's degree in Life Science. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred.
- 2-4 years clinical experience or 2-3 years clinical experience and 1-year pharmacovigilance experience.
- Demonstrates ability to lead project work. Proven success in results-driven process management.
- Demonstrates ability to work collaboratively in team environment.
- Demonstrates understanding of the changing regulatory environment and impact to case management process
- Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA).
- Competent in case processing processes, procedures, conventions.
skills: Drug Safety, Adverse Event (AE) Reporting, Case Processing, Serious Adverse Event (SAE) Reporting
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.
