Drug Safety Associate (JP4661)
Thousand Oaks, CA.
GPS – Safety Management
11+ months (likely extensions)
3Key Consulting Inc. is recruiting for a Drug Safety Associate
with 2 - 6 years’ experience (depending on education) and knowledge of global regulatory requirements for pharmacovigilance for a global, CA-based, bio-pharmaceutical company.
This individual will report to a Manager or Sr. Manager in Global Patient Safety, Pharmacovigilance Operations and/or Case Management. This individual may be responsible for any/all of the following activities:
Top Must-Have Skill Sets:
- Performing follow-up (queries, case processing) activities for US safety cases.
- Oversight of case processing through monitoring activities.
- Case quality review.
- Other case processing functions or special projects as requested.
- Understanding of US pharmacovigilance regulatory requirements.
Day to Day Responsibilities
- Understanding of global regulatory requirements for pharmacovigilance.
- Familiarity with clinical development processes.
- Case processing experience.
- Ensure vendor compliance with approved processes and training requirements.
- Oversee case quality of all global ICSRs (CT and PM) including analysis and reporting of trends in quality measures.
- Lead/Single point of accountability for managing one or more key vendor relationships for ICSR processing.
- Case processing point of contact for case related activities with assigned business partners.
- Case processing point of contact for audit related activities related to case processing.
- Accountable for measuring quality against contractual safety agreements.
• Master’s degree
• Bachelor’s degree and 2 years of directly related experience
• Associate’s degree and 6 years of directly related experience
Why This Position Is Open:
- Excellent verbal and written communication skills; ability to interact effectively over the phone.
- Proficient skills in interacting with healthcare professionals, patients and consumers.
- Experience in working with multiple safety databases.
- Highly organized and demonstrates consistent attention to detail.
- Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills.
- Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines.
- Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required.
- Must have the ability to work collaboratively as part of a team in a fast-paced dynamic environment and cross functional interactions.
- Candidates with case processing and/or medical/health care/insurance call center experience preferred.
Need additional support for the team.
Employee Value Proposition:
Does not meet minimum requirements.
Phone and in person up to 4 Amgen staff.
We invite qualified candidates to send your resume to email@example.com
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.