Pharmacovigilance Operations Professional

Job description

·  Job facts

Job Description

Safety Data Transformation Lead/Specialist

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
·  Ensuring oversight, coordination, delivery and inspection readiness of activities supporting the ICSR process in collaboration with the vendor, Operations Vendor Interface, 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. Develops, maintains and reviews 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
·  Proactively identifying areas of potential case processing inconsistency, reviews and identifies trends in compliance or quality and works with appropriate stakeholders to define tactics to remediate and drive quality, including effectiveness measures.
·  Driving 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.
·  Leading change initiatives to assigned sub-processes, e.g. impact assessment of revised legislation in reference to process changes and training. Responsible for synchronising process improvement plans with other process owners within the value chain and other interfacing processes, in collaboration with the case processing BPO.
·  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.
·  Driving development and readiness for outsourcing additional activities to vendor in conjunction with Operations Vendor Interface. Preparation of activities identified for outsourcing, including development of oversight mechanisms in collaboration with Operations Vendor Interface, as appropriate
·  Sustaining effective partnerships with key stakeholders across PDS and the wider Roche organization to ensure success of Operations related activities.
·  Partnering globally, both across and outside Roche in 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).
·  Developing 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:

·  Contribute to the delivery of the business strategies, and clearly articulate Data Transformation strategy and vision to stakeholders and customers
·  Contribute to the definition and development of objectives and priorities, which are regularly reviewed and revised on a rolling basis, remaining anchored to the overarching mission of Data Transformation
·  Employ a systems thinking and entrepreneurial mind-set
·  Apply a quality mindset, and support the development, delivery, maintenance and oversight 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 Roche values, Leadership Commitments and the PD/PDS Strategy.
·  Represent PDSO at internal and external forums, communicating PDSO accountabilities, deliverables and achievements as appropriate.

Professional and Technical Requirements:

Education/Qualifications

Minimum: Degree level qualification

Strongly desired: Postgraduate Degree (PhD, PharmD, MSc, MD) or qualification in pharmacovigilance

Experience, Skills, Knowledge:

·  Appropriate industry experience, preferably in areas relevant topharmacovigilance.
·  Strong knowledge of global Pharmacovigilance regulatory obligations.
·  Effective leadership, management and communication skills, demonstrating ability to input and deliver on strategy, and with the ability to motivate and lead individuals for which they have no line management responsibility.
·  Strong communication skills, demonstrating professional maturity, competence and confidence.
·  Proven ability to lead projects and teams to successful conclusion demonstrating initiative and accountability
·  Well developed influencing and negotiating skills, with the ability to influence at all levels of an organisation, without direct authority.
·  Good conflict management and resolution skills.
·  Creative problem solving in a complex, process-focused environment.
·  Excellent interpersonal skills, builds strong sustainable relationships with internal and external stakeholders
·  Ability to work in global line or matrix teams in accordance with the Roche leadership commitments and values, and to work across geographic areas, business settings and cultures, including in a virtual environment.
·  Proven track record of effective, independent decision-making; makes good business decisions and exercises sound judgment

Travel Requirements: International travel required (less than 10%)

·  Who we are

Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions. Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.