Senior PV Officer
Outside IR35, Hybrid working 1 - 2 days in the office per week.
The jobholder is accountable for delivering the strategy for the transformation and delivery of data in order to meet both current and future requirements for a variety of safety related data outputs.
The jobholder is responsible for oversight of the processing and reporting of ICSRs via the utilisation of current/future safety systems, and partners to ensure that the quality/usability of ICSR outputs conforms with agreed customer requirements (
The jobholder is accountable for:
(Depending on experience, may include any/all of the following)
- Supporting the oversight of the processing and reporting of the acquired ICSR data (in collaboration with Affiliates for local sources), via effective utilisation of current/future technologies; ensuring efficiency, quality and compliance of the various safety data/information outputs generated. Monitors workload, compliance and quality across the ICSR global footprint to ensure internal and external performance standards are maintained
- Supporting the oversight, coordination, delivery and inspection readiness of activities supporting the ICSR process in collaboration with the vendor, Operations Vendor Interface, relevant BPOs and GPOs, e.g. Literature process, Quality Review, Serious Adverse Event (SAE) reconciliation, Blind Breaks, SUSAR distribution, HA submissions. Responsible for quality and compliance of assigned processes. Supports the development, maintenance and review of metrics and KPIs to identify opportunities for continuous improvement in associated ICSR sub-processes. Responsible for maintenance and development of applicable business process documentation and training, in collaboration with PDSO colleagues, PVQM and PDQ, and may be required to represent the process in audits and inspections
- Supporting the development and implementation of processes and relevant human interventions (eg human in the loop) activities for AI augmented activities that permit oversight of operational ICSR delivery and quality.
- Supporting change initiatives to assigned sub-processes, e.g. impact assessment of revised legislation in reference to process changes and training.
- As a member of the PDSO BPO Support network, support Case Processing Governance, provide subject matter expertise, and act as a point of contact for queries and issue escalation for stakeholders or vendor personnel regarding the ICSR Process.
- Oversight of delivery of Discrete ICSR Package Projects (DIPPs) across PDS Operations sites, in partnership with Operations Vendor Interface. Monitors and tracks status until completion. Resolves and escalates identified issues.
- Supporting outsourcing additional activities to vendor in conjunction with Operations Vendor Interface.
- Sustaining effective partnerships with key stakeholders across PDS and the wider organization to ensure success of Operations related activities.
- Developing and maintaining knowledge of the use of relevant new methods and technologies (eg artificial intelligence) for safety data processing.
- Working closely with PDSO BPOs to establish ?inspection readiness? approaches to demonstrate ICSR process delivery quality, when using new processing approaches (eg future AI enabled safety systems etc).
- Supporting the development of innovative ways to manage and transform wider types of safety-relevant data (eg patient reported outcome data, electronic health record data, market exposure data) and partner with global customers to understand their data and usability needs.
- Developing and maintaining knowledge of how technologies can be can be utilised for the management/delivery of non-ICSR safety information, in order to deliver novel, high quality information for scientific analysis.
The job holder will be expected to:
- Support the delivery of the business strategies, and clearly articulate Data Transformation strategy and vision to stakeholders and customers
- Develop a systems thinking and entrepreneurial mind-set
- Apply a quality mindset, and support the development, delivery, and maintenance of the Quality Management System (QMS), in line with an holistic approach across Safety Operations.
- Work in an agile manner, forming and concluding squads/sprints as necessary and taking on the role of Squad Lead when appropriate
- Role model behaviours that delivers an agile organisational culture that is in line with the company values, Leadership Commitments and the PD/PDS Strategy.
Professional and Technical Requirements:
Experience, Skills, Knowledge:
- Appropriate (2 years minimum, desired) industry experience, preferably in areas relevant to pharmacovigilance,
- Good knowledge of global Pharmacovigilance regulatory obligations.
- Strong communication skills, demonstrating professional maturity, competence and confidence.
- Effective team player, with proven ability to support/lead projects to successful conclusion, demonstrating initiative and accountability
- Proven abilities in managing objectives, goals and other priorities to effective and efficient conclusion
- Developing influencing and negotiating skills
- Good conflict management and resolution skills.
- Creative problem solving in a complex, process-focused environment.
- Excellent interpersonal skills, with the ability to build strong sustainable relationships with internal and external stakeholders
- Ability to work in global line or matrix teams in accordance with the companies leadership commitments and values, and to work across geographic areas, business settings and cultures, including in a virtual environment.
- Effective/independent decision-making; exercising good judgment
- Agency: Achieva Group Limited
- Reference: BH-33811
Website: Achieva Group Limited
- Posted: 15th September 2022
- Expires: 13th October 2022