Global Pharmacovigilance Operations Manager

Global Pharmacovigilance Operations Manager

Sobi

Stockholm, Sweden

Job Description

The Global PV Operations Manager is responsible for working with the Sobi case processing system including vendor processing functions.

Support collection, processing, follow-up, reporting, documenting, archiving and reconciliation of safety data for all types of individual case safety reports (ICSRs).

Responsible for working across Sobi and case processing vendor functions to ensure safety case reports are processed and assessed to appropriate standards and timelines, to ensure global reporting compliance and provide value for signal assessment.

Addresses queries from the vendor teams, monitors quality and drives improvements to ensure that the ICSR activities are conducted to the highest quality standards in compliance with GVP, GCP and regulatory requirements.

The Global PV Operations Manager will be working collaboratively with the members of the Systems and Operations team.

Key Responsibilities/Scope of the Job

• Proactively identify possibilities to optimize case management, case management vendor oversight and process improvements within SOBI;
• Responsible for review of KPIs and work with methods to monitor compliance of the global case management vendor;
• Responsible for appropriate vendor QC models and monitoring of these;
• Ensure appropriate certification of case processing vendor staff is in place including test cases for access to safety database;
• Support day-to-day management of the DrugSafety-mailbox, e.g. track, organize, categorize, assign and ensure emails are addressed appropriately in a timely manner by the relevant GPV & Patient Safety function(s);
• Support for maintenance of any other mailbox in the global case management team, e.g. archiving, keeping e.g. playbook(s) and FAQ(s) up to date, key contact person and SME for the mailbox management process;
• Pro-actively identify potential for mailbox improvements and best practices;
• Perform in-house ICSR reconciliation activities and support the coordination of the reconciliation activities;
• Perform download from Authority Databases (e.g. EudraVigilance) or ensure vendor performs the activity (e.g. Health Canada) as required;
• Provide guidance on ICSR-management investigations and issues or inquiries raised by the case processing vendor;
• Pro-actively identify quality and compliance issues and support non-conformance investigations related to the vendor 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 the 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

Education/Learning Experience/Work Experience:

• 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

Required:

• Able to work effectively both independently and collaboratively across the organisation;
• Delivery focused with ability to exercise judgement, make decisions, and take action to complete assignments;
• Good attention to detail;
• Team player;
• High Ethical Standards.

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