Maidenhead, Berkshire, ENGLAND, United Kingdom
Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create Seqirus, now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.
This position is responsible and accountable for both strategic and operational PV activities, business administration for all PV functions by working closely with the Head Pharmacovigilance and PV leadership team. Responsible for logistical planning, execution, and control of the PV operations including the set-up of Seqirus safety database, the formation of her/his team building Seqirus processes and business technology supporting best medical safety practices. Work in close collaboration with the BRP leads, and EUQPPV.
This position is the coordinator, oversight and point of accountability for vendors hosting Seqirus safety database (management and maintenance) and processing the Individual Case Safety Reports (ICSRs) from all sources ensuring compliance with regulatory requirements.
The Head must have intimate and at all-time current knowledge of the PV systems regulations, ie relevant GVP Modules for EMA and Part 11 for FDA
1. Lead a group of diverse PV operational experts (from technology and systems management to medical cases management flow) providing Operations strategy and oversight of vendors. Accountable for talent and career development of direct reports, including performance management. Engineer and drive the transition of safety databases from former ‘parent companies’ into a safety database, structured to Seqirus products and compliant with international regulatory requirements including electronic transmission of ICSRs (E2B R2/R3). Organize and ensure business continuity in the exit of legacy companies Transition Services Agreement (TSAs) to Seqirus Operations Department. Write and update the contracts and Pharmacovigilance Agreements (PVAs) between Seqirus PV and the vendors/CROs hosting the database or handling cases processing.
2. Responsible for PV Operations resource & budget planning and management. Represent Global Head PV on operational issues. Manage flow of operational information as needed to/from other departments and PV stakeholder functions ie Medical Information, medical affairs, local safety officers, license partners and/or distributors.
3. Responsible for oversight on delegated operational PV activities for ICSR processing (all sources, including SAEs/SUSARs and events of interest from clinical studies), ICSR flow and prioritization, ICSR compliance monitoring (triage to submission), quality outputs deliverables from Seqirus safety database for the writing of safety aggregate documents.
4. Define and implement PV processes in accordance with international PV legislation including the preparation of corresponding PV Standard Operating Procedures/ Work Instructions and other PV documents Ensure high level of productivity, efficiency and quality of PV business processes to achieve operational excellence. Provide management with project status, highlighting business critical items and elements of risk.
5. Support of PV related GVP, GCP and GMP audits & inspections, including follow up activities for corrective and preventive actions (CAPAs) to health authorities and tracking of commitments; Coordinate the preparation and conduct of PV trainings together with the Development Training Team and ensure that the relevant PV training is assigned to Seqirus personnel and other stakeholders as appropriate.
•Global responsibility for the Seqirus database, related SOPs and conventions
•Oversight and accountability for the vendors’s performance and compliance
•Management of global and diverse, multiskilled teams
•Responsible of the Ops budget
Impact / Influence / Liaison:
•Ensure an efficient, compliant PV systems structure with tight oversight of the vendors
•Design and implement Innovative, efficient processes to ensure support and best medical data outputs to the Risk-Benefit physicians
•First line support and representation of Seqirus during inspections to ensure Seqirus compliance with the GVP systems and part 11
•Rapidly adapt and implement regulatory changes
•Represents Seqirus in PV users group (ie Argus, Eudravigilance) and for related guidances review, positively positioning the company
•Proven pharmaceutical industry experience or CRO with 3-5 preferably in Development or pharmacovigilance, handling Database structure, validation and software lifecycle management ( i.e. Oracle, Argus or ARISg)
•Demonstrated leadership in innovation of pharmaceutical development processes and in technical approaches
•Demonstrated success in resource planning and management;
•Proven record in leading/managing cross-functional teams in Clinical Safety and/or PV Operations
•Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills
•Proven track record in innovative approaches to continuous improvement and change management in clinical safety and pharmacovigilance systems, processes and standards
•Proficiency in problem-solving within a highly complex environment
•Good networking and team skills for successful cooperation with internal and external customers
•Knowledge of drug safety regulatory requirements and general project management;
•Excellent communication and influencing skills and High ethical standards as well as personal credibility, the ability speak forthrightly for the right systems for Seqirus
•Analytical and logical; is able to design and implement innovative improvement plans
•Ability to successfully manage and prioritize multiple critical issues simultaneously.
•Ability to work effectively and collaboratively across the organization with a focus on global multifunctional teams and in a changing environment
If you feel that your profile is in line with the role scope and you would like to apply for the opportunity, please send your CV to email@example.com