Drug Safety Associate Lead

California, United States of America

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The Position

Summary of Position:

The Sr. PV Ops Associate supports and assists in the activities related to adverse event (AE) information received by US Drug Safety. The Sr. PV Ops Associate is responsible for activities associated with the coordination and monitoring of Individual Case Safety Reports (ICSRs), MAP operations, Study Management operations, and any other responsibilities related to PV operations. Responsibilities are performed under the direction of the PV Operations Head.  Responsibilities vary depending on the business needs to which the Sr. PV Ops Associate is assigned.

Key Accountabilities:

  • Performs PV approver responsibilities for MAP related activities as required
  • Oversees and is responsible for supporting Late Case Investigations (LCIS) activities
  • Demonstrates high level proficiency and expertise of drug safety concepts to include monitoring, tracking, and completion in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs)
    • Responsible for case assignments to PV Clinical support personnel and ensures timely completion of ICSRs
    • Assist in coordinating quality reviews performed by PV clinical group
    • Support day to day operations including but not limited to query response from GVP service providers
  • Oversees and 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. This includes: a) Communication with MAP vendors; b) management of vendor conducting SDQC, including appropriate QC; receiving, QC and tracking data files.
    • 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.
    • Provide regular status updates, highlight potential risks and escalate issues to line manager.
    • 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.
  • Oversees and 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
    • Oversight of study management mailbox on a daily basis to ensure items have been actioned 
  • Supports submission related activities to health authorities as required
  • Able to identify potential business gaps and assists in the development and implementation of process solutions.
  • Assists or leads special projects as assigned by and under the direction of the Head of PV Operations and/or other Safety personnel.
  • Assists in the tracking and investigation of case processing related metrics as required
  • Identifies compliance trends and formulates action plan as needed to address compliance issues.
  • Acts as a lead for PV Operations during audit/inspection
  • Able to identify potential business gaps and oversees and supports Leads in the development and implementation of process solutions.
  • Acts as single point of contact with key stakeholders for safety related activities.
  • Supports the Team in safety related initiatives with minimal or no supervision.
  • Leads or assists the mentors in the training of new personnel.
  • Participates in the education of internal and external stakeholders in safety related activities.
  • Leads the tracking and investigation of case processing related metrics.
  • Oversees the PV System Master File (PSMF) to ensure regulatory compliance
  • Collaborates with PV Clinical and SP PV Oversight teams as needed

Competencies Identified for Success:

  • Ability to translate complex data trends to actionable steps
  • Demonstrates strong business expertise related to PV environment
  • Works effectively, independently and collaboratively.
  • Strong organizational skills, detail oriented and adapts in a fast paced, changing environment.
  • Ability partner effectively with the data analyst and translate and interpret the data for all PV related activities
  • Demonstrates ownership, initiative and accountability.
  • Excellent communication skills, both written and verbal.
  • Ability to prioritize tasks in a timely manner.
  • Ability to interact effectively in a multifunctional, 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.
  • Exemplifies strong, dynamic leadership.

Education, Experience, and Other Requirements:

  • Bachelor degree (required).
  • Minimum of 5 to 7 years of Pharmacovigilance safety related experience (preferred).
  • Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite) (Preferred).
  • Medical terminology experience.
  • Writing experience; science/medical writing highly desirable.
  • Ability to travel as required

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

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