Remote Manager, International Office (PV)
Remote Emeryville, CA 12084 US
- 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.
- 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
Although this hasn't been an issue at The Planet Group, 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 The Planet Group.