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PV Systems Solutions & Innovations Associate

S San Francisco, CA 94080

Posted: 03/28/2025 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 618589 Is job remote?: Hybrid Country: United States

Job Description


Summary of Position:

The PV Systems Solutions & Innovations Associate provides operational support to the US Patient Safety Clinical and Vendor Oversight teams to ensure proper performance of baseline PV compliance based responsibilities. This is done through implementation and regulation of global processes, local legislation, case investigation, and study management. Responsibilities are performed under the direction of the Senior Manager, PV Systems Solutions of Operations & Innovations.

Key Accountabilities:
  • Perform Individual Case Safety Reports (ICSR) Activities Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to health authority
  • Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes
  • Assists and collaborates with Global ICSR team to inform on US Affiliate ICSR compliance performance and risks
  • Performs daily workflow coordination and initial review of cases that are processed by our internal teams
  • Oversees the enrollment process and proper onboarding of GVP vendor Assists in the tracking and investigation of case processing related metrics
  • Supports Late ICSR Investigation and Risk Mitigation Strategy Ability to review late case(s) to determine root cause analysis (RCA) and corrective action preventative action (CAPA) as needed
  • Provide regular ICSR compliance updates, highlight potential risks or trends and escalate issues to Team Leads and US PS Leadership
  • Support implementation of CAPAs and business units where required on appropriate CAPA to any findings
  • Continuous review of ICSR compliance trends to inform risk mitigation strategy to avoid non-compliance for the US affiliate Liaise and collaborate with vendor oversight teams to ensure external and internal stakeholder compliance
  • 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)
  • Ensures all US Medical (USM) studies have been reviewed and assessed by the Patient Safety and Risk Management Partners with key stakeholders to ensure proper assessment and documentation of study related decisions Escalates compliance risks or issues to management when identified
  • Assists in the tracking and investigation of metrics as required
  • Supports MAP Operational related activities Perform reconciliation related activities for Market Research Patient (MAP) support programs and responsible for tasks related to GoMAP to ensure continuous data integrity
  • Run operational metrics reports on a routine basis, identify required follow-ups, and work with the appropriate PV Systems Solutions and Innovations team member and/or Vendor Leads to ensure appropriate follow-up is completed
  • Responsible for executing Source Data QC (SDQC) of in scope MAPs on a routine 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 Service Provider Training, CTV, SDQC, contracts) are tracked in GoMAPensuring continuous data integrity Assists in the tracking and investigation of metrics as required
  • Vendor Oversight for Outsourced Pharmacovigilance (PV) Activities Understand the vendor management framework and translate the requirements into reporting deliverables
  • Support Lead on all operations performed, including training and the implementation of policies/procedures that ensure effective and compliant operations
  • Develops agendas and facilitates meetings as needed
  • Tracks status of metrics for outsourced activity and escalates to Senior Manager, PV Systems Solutions of Operations & Innovations as required
  • Communicates closely with cross functional teams within US PS to achieve the appropriate level of support to ensure oversight of outsourced activities Leads or assists in the tracking, investigation and trending of case processing related metrics (e.g., late case investigation) including compliance related issues set by the vendor management strategy team
  • Activity Classification and Promotional Review Material
  • Responsible for oversight of receipt and processing of activity classification requests and/or safety-related queries.
  • Oversight and review of approved Promotional Review Committee (PRC) promotional marketing materials for proper oversight of market research programs and patient support programs (MAP).
  • Additionally the PV Solutions Systems and Innovations Associate will be accountable for the following;
  • Ability to identify potential business gaps and assist in the development and implementation of process solutions
  • Continuous evaluation of operational remit to assess process improvements, and opportunities to consolidate or outsource PV activities Assists or leads special projects as assigned by and under the direction of US PS Leadership
  • Participates in the education of internal and external stakeholders in safety related activities by creating and assigning required training
  • Act as subject matter expert/point of contact for any audit/inspection related activities
  • Project Management responsibilities, including the development and management of detailed project schedules and scope of work

Competencies Identified for Success:
  • 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
  • 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. Ability to actively exchange knowledge and ideas
  • Demonstrates leadership skills

Education, Experience, and Other Requirements:
  • Minimum Bachelors degree (Preferred) or 5-10 years PV experience. Degree in Life Science or related field (Preferred)
  • Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite and Google Applications) (Preferred)
  • Proven ability to solve problems creatively
  • Familiarity with project management software tools, methodologies, and best practices
  • Excellent analytical skills and ability to translate complex data trends to actionable steps
  • 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
  • Excellent communication skills, both written and verbal
  • Strong interpersonal skills and extremely resourceful
  • Ability to travel as required 






Pay Rate Range: $30-40/hr depending on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About S San Francisco, CA

Ready to find your dream job in the vibrant area around South San Francisco, California? This bustling region, nestled in the heart of the Bay Area, offers an array of unique benefits and growth opportunities for job seekers. With its proximity to iconic landmarks like the Golden Gate Bridge and Alcatraz Island, a thriving culinary scene featuring local favorites like clam chowder bread bowls at Fisherman's Wharf, and a rich cultural tapestry showcased in renowned art galleries like the San Francisco Museum of Modern Art, there is no shortage of reasons to kickstart your career here. Explore our job listings today and discover why pursuing your career in this enchanting region is the perfect choice for your professional growth and personal fulfillment.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.