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Drug Safety Associate (JP4661)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title:  Drug Safety Associate (JP4661)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  GPS – Safety Management
Duration: 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.
Job Description:
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:
  • 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.
Top Must-Have Skill Sets:
  • Understanding of global regulatory requirements for pharmacovigilance.
  • Familiarity with clinical development processes.
  • Case processing experience.
Day to Day Responsibilities
  • 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.
Basic Qualifications:
• Master’s degree
• Bachelor’s degree and 2 years of directly related experience
• Associate’s degree and 6 years of directly related experience
  • 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.
Why This Position Is Open:
Need additional support for the team.
Employee Value Proposition:
High-visibility project.
Red Flags:
Does not meet minimum requirements.
Interview process:
Phone and in person up to 4 Amgen staff.
We invite qualified candidates to send your resume to  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 You are also welcome to share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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