This remote opportunity is ideal for a highly experienced pharmacovigilance professional ready to apply their in-depth knowledge of ICSR case processing. As a Subject Matter Expert, you will be the first line of decision-making for case processing issues, ensuring the highest standards of quality and global compliance. The role offers the chance to collaborate with internal and external parties, provide critical input on training materials, and troubleshoot a wide variety of complex problems. This position is perfect for a technical expert who thrives on improving processes and safeguarding compliance for a major pharmaceutical company.
location: Telecommute
job type: Contract
salary: $50 - 62 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Communicates with internal and external parties on case contents, and to reply to related queries
- Makes first line decisions on case processing matters for prioritization, FU significance, seriousness, labeling, coding queries, etc
- Performs or initiates case corrections, as needed
- Performs SME services for ICSR processing queries by the vendor
- Supports late case investigations by the regional PV Case Management team.
- Provides Subject Matter Expertise (medical/technical.) for the creation of training materials in collaboration with the PV Training team.
- Facilitates finalized training sessions (PV Processes and systems) for vendors and PV Process staff in collaboration with PV Training team.
qualifications:
Education & Qualifications
Required:
- MS degree in life sciences or equivalent
- 5+ years relevant experience with ICSR case processing (PV case processing) and expertise within Pharmacovigilance
- In-depth knowledge and understanding of PV Process regulatory requirements and ICSR processing procedures globally and in Americas region
- A technical expert within the organization, with extensive knowledge within their chosen specialty and developing knowledge of related disciplines.
- Has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.
- Provides solutions to a wide variety of problems of greater complexity that require the regular use of creativity and ingenuity, while safeguarding Astellas' compliance.
- Ensures case processing and case quality are maintained at highest standards at all times
- Strong interpersonal skills and multi-cultural /intercultural awareness; able to develop effective relationships through collaboration.
- Good communication skills in English (written and spoken)
- RN
skills: Pharmacovigilance
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.
