PV Operations Associate I in South San Francisco, CA at APEX Systems

Date Posted: 12/4/2019

Job Snapshot

Job Description

Job #:  1029758


A major biotech company is looking for a Pharmacovigilance Operations Associate to join their team in South San Francisco, CA! If interested in the role, please send your most up-to-date resume to ascrivner@apexsystems.com.
Job Title: PV Operations Associate I 
Location: South San Francisco, CA
The PV Operations Associate provides operational support to ensure oversight and PV compliance through implementation of the Global MAP process, local legislation for MAP and study management. Responsibilities are performed under the direction of the Head of PV Operations.
Key Accountabilities:
  • Supports all MAP Operations related activities
    • Perform reconciliation related activities for Market Research Patient (MAP) support programs and responsible for tasks related to MAP Global Tracking Tool (GTT) to ensure continuous data integrity.
    • Run operational metrics reports on a routine basis, identify follow-up’s required, and work with the appropriate PV Operations head and/or vendor lead to ensure appropriate follow-up is completed.
    • Oversees operational aspects of US MAP Service Provider Qualification Process including: curation and upkeep of US MAP Service Provider qualification portal, ensuring consistency and fidelity of all Service Provider lists, management and assignment of new assessments to PV Operations head and/or vendor lead.
    • Responsible for executing Source Data QC (SDQC) of in scope MAPs on a quarterly basis.
    • Ensure all MRP and PSP programs documentation (including SP training, CTV, SDQC, contracts) are tracked in Tracking Tool ensuring continuous data integrity.
    • Provide support to business/functional partners by answering questions and providing advice on good MAP practices.
    • Act as point of contact in the region for all communications in relation to MRP and PSP including participation in regular MAP lead meetings and at regional Business Planning meetings.
    • Oversee and support implementation of CAPAs and support business units where required to determine appropriate CAPA to any findings and ensure effective closure in a timely manner.
    • Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes.
  • Supports all study management related activities.
    • Responsible for oversight, triage, and tracking of incoming study document review request.
    • Responsible for performing Case Transmission Verification (CTV).
    • Ensuring all USMA studies have been reviewed by PV Clinical Group.
  • Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to health authority.
  • Participates in the education of internal and external stakeholders in safety related activities.
  • Act as SME point of contact for any audit/inspection related activities.

Competencies Identified for Success:
  • Ability to translate complex data trends to actionable steps.
  • Demonstrates strong business expertise related to PV environment.
  • Excellent communication skills, both written and verbal.
  • Ability to interact effectively in a multi-functional, multidisciplinary team setting.
  • Sound decision making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility.
  • Ability to actively exchange knowledge and ideas.

Education, Experience, and Other Requirements:
  • Minimum Bachelor’s degree or 12-15 years PV experience.
  • Degree in Life Science or related field 
  • Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite)
  • Writing experience; science/medical writing highly desirable.
  • Ability to travel as required

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.