South San Francisco
California, United States of America
Job Title: PV Operations Associate
Department: US Medical Affairs
Location: South San Francisco
Reporting: Head of PV Operations
Summary of Position:
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.
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.
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
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.
Participates in the education of internal and external stakeholders in safety related activities.
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.
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
Works effectively, independently and collaboratively.
Strong organizational skills, detail oriented and adapts in a fast paced, changing environment.
Demonstrates ownership, initiative and accountability.
Excellent communication skills, both written and verbal.
Able to translate complex tasks and execute in a timely manner to ensure compliance
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.
Demonstrates leadership skills.
Education, Experience, and Other Requirements:
Minimum Bachelor’s degree (Preferred) or 12-15 years PV experience.
Degree in Life Science or related field (Preferred)
Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite) (Preferred).
Writing experience; science/medical writing highly desirable.
Ability to travel as required
CMG Operating Principles
I put the patient first, always
I am obsessed with meeting customer needs
I act on behalf of the whole company, not just my team
I am inclusive
I have a growth mindset
I act with urgency
I am accountable
I radically simplify and prioritize for impact
I follow the science
I build our reputation
External Link: https://www.gene.com/careers/commercial-operating-principles
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.
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