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Remote Manager, International Office (PV)

Emeryville, CA 12084

Posted: 11/28/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 592085 Is job remote?: Yes Country: United States

Job Description

Pay 55-65/h depending on experience
  • Work closely with the Director, GPS International Office to support the overall strategy for GPS International Office.
  • Supports patient safety operations in affiliates by working collaboratively with vendors, affiliates and alliance partners.
  • Responsible for the identification, collection, analysis and visualization of relevant data to support the GPS International Office and the International Operations Committee [IOC].
  • Responsible for scheduling, setting agendas, taking minutes and following up on action items for relevant meetings including but not limited to the IOC and EU QPPV meetings.
  • Active participant in team and cross functional meetings, including the joint International Office and QPPV meetings.
  • Builds relationships with the regional and local QPPV’s.
  • Supports the EU QPPV in the maintenance of the EU QPPV Office and QPPV for a as needed.
  • Ensures central management of information for patient safety operations in affiliates.
  • Supports the monitoring of Key Performance Indicators (KPI’s) related to the health of patient safety operations in affiliates.
  • Provides regular updates on the health of the International Office activities to the team.
  • Works closely with established vendors and business partners to ensure patient safety operations in affiliates are supported.
  • Supports the review and analysis of pertinent regulatory intelligence activities.
  • Provides impact analysis of local PV regulatory changes on regional and GPS wide PV system and vice versa.
  • Facilitates relationships and communication between central GPS functions and relevant cross-functional and affiliate stakeholders and ensures escalation of emergent safety and management 
  • Partners with GPS QMO to align GPS SOPs processes and tools to meet operational and training needs of patient safety operations in affiliates.
  • Partners with the EU QPPV and other regional and local QPPVs to ensure accuracy of the required PSMF’s.
  • Supports coordination and delivery of safety-related documents e.g. PSMF.
  • Liaises with Business Partners for local expertise, local document creation and legal documentation, as needed.
  • Responsible for audit and inspection support as it relates to patient safety operations in affiliates.
  • Responsible for facilitating the QA Change Control process on behalf of GPS as it relates to patient safety operations in affiliates.
  • Supports the Director, International Office with maintaining the agreed upon communication plan for GPS International including the affiliates.
  • Provides key informational updates to Communications for inclusion in departmental meetings, publications and communications (Newsletter, website, etc.).
  • Encourages affiliate team members to participate in GPS-wide events and campaigns.
  • Champions patient safety’s values and principles; positively contributes to GPS’ culture.
  • Supports the Director, International Office in budget and resource planning for GPS International Office.
  • Provides relevant input and guidance to GPS projects and provides contribution and input into the establishment of goals to support broad functional objectives.

  • Minimum five (5) years of experience in Biotech/Pharmaceutical industry in operational roles preferably in a pharmacovigilance role.
  • Demonstrated experience and knowledge of PV procedures.
  • Demonstrated experience of working with business partners, vendors / third party providers.
  • Excellent knowledge of relationship building and cross functional collaboration.
  • Experience of working with and supporting local PV systems worldwide, including but not limited to PV affiliate support.
  • Excellent oral and written communications, including experience in public speaking and group facilitation.
  • Experience of data collection, analysis and visualization highly desirable.

Other Qualifications:
  • Strong knowledge of global drug safety regulations including but not limited to FDA, EMA and GVP)
  • Strong interpersonal and presentation skills, including the ability to liaise with senior
  • Expertise in negotiation and identifying areas of mutual interest required to achieve
  • Excellent oral and written communications
  • Ability to deal with ambiguity and make
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