Provides medical support with emphasis on the intake of medical product experiences. 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.
location: Telecommute
job type: Contract
salary: $40 - 45 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Conducting oversight of vendors who identify and collect adverse event and product quality complaint information and complete in-take of Pharmacovigilance safety and product complaint reports in Company's Systems.
- Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event and product complaint information is performed in a compliant and timely manner to comply with global regulations.
- Supporting the business strategy of assisting internal and external customers in collecting information for product safety reports, products complaints related to Company products.
- Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met. Remaining current on knowledge and skills required for supporting Company customers.
- Supporting vendor case quality, and productivity metrics by exhibiting 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.
- 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.
- Conducting oversight to ensure the vendor is effectively communicating using various mediums and establishing rapport with customers, colleagues, and interdepartmental groups.
- Conducting oversight in the vendor's use of multiple databases to document adverse event and product complaint information.
- Supporting implementation of strategies to enhance PDI excellence in providing the highest level of customer experience.
- Acts as an adverse event and product complaint intake subject matter expert.
- Other duties may be assigned based on the need or work requirement of the organization.
qualifications:
Required Qualifications:
- Bachelor's degree of RN, BSN, or BS Pharm/PharmD required.
- 2-4 years' clinical healthcare and previous pharmaceutical industry experience.
- Demonstrates ability to lead project work.
- Proven success in results-driven process management.
- Core knowledge of Industry regulations (ICH, FDA, EMEA, MHRA).
- Demonstrates strong attention to detail and problem-solving skills
- Demonstrates strong verbal communication skills with external and internal customers
- Demonstrates strong (speed and accuracy) documentation skills
- Pharmaceutical industry contact center experience preferred.
skills: FDA, Drug Safety, ICH Regulations
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.
