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Global Pharmacovigilance Operations Manager

2 months ago

Stockholm, Stockholm, Sweden Sobi Full time
Job Description

The Global Pharmacovigilance Operations Manager is responsible for overseeing the pharmacovigilance operations across the organization, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities:
  • Proactively identify opportunities to optimize case management and process improvements within Sobi.
  • Responsible for reviewing KPIs and working with vendors to monitor compliance.
  • Ensure appropriate vendor QC models and monitoring of these.
  • Ensure certification of case processing vendor staff, including test cases for access to safety databases.
  • Support day-to-day management of the DrugSafety-mailbox, including tracking, organizing, categorizing, assigning, and ensuring emails are addressed appropriately in a timely manner.
  • Support maintenance of other mailboxes in the global case management team, including archiving, updating playbooks and FAQs, and serving as a key contact person and SME.
  • Proactively identify potential for mailbox improvements and best practices.
  • Perform in-house ICSR reconciliation activities and support coordination of reconciliation activities.
  • Perform downloads from Authority Databases (e.g., EudraVigilance) or ensure vendors perform the activity (e.g., Health Canada) as required.
  • Provide guidance on ICSR-management investigations and issues or inquiries raised by the case processing vendor.
  • Proactively identify quality and compliance issues and support non-conformance investigations related to vendors and internal issues.
  • Responsible for Sobi safety database impact assessments, configurations, and user testing as needed.
  • Responsible for database migration projects, including document review and user testing.
  • Responsible to provide input to the update of Case processing manuals and support delivery of training on manuals and other case management quality documents.
  • Responsible for training of different roles in the Sobi safety database (end-user training) for Sobi personnel (affiliate and Sobi HQ).
  • Support the Global PV Case Management Lead in regulatory intelligence review impact assessments.
  • Support in inspections and audits, as needed.
Qualifications:
  • University-level qualification in biosciences, healthcare, or pharmacy.
  • At least 3 years' experience post-graduation in the pharmaceutical industry within the area of Pharmacovigilance, including case processing activities.
Skills/Knowledge/Languages:
  • Knowledge of GVP and GCP.
  • Fluent English - written and spoken.
Personal Attributes:
  • Able to work effectively both independently and collaboratively across the organization.
  • Delivery-focused with ability to exercise judgment, make decisions, and take action to complete assignments.
  • Good attention to detail.
  • Team player.
  • High Ethical Standards.