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SOP & Compliance Manager (Pharmacovigilance)-Seqirus

Maidenhead, Berkshire, Maidenhead, United Kingdom

Posted: 4-Oct-2016

Ref#: 12345699081


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.


Job Summary:

This position is responsible for ensuring consistency and compliance of PV Business Process against Seqirus standards and regulatory requirements including preparation and maintenance of Standard Operating Procedures, Working Instructions as wells as other convention documents

Principal Accountabilities:

  • Ensure alignment of PV documentation with both regulatory requirements, Seqirus policy as well as quality manuals
  • Work in close collaboration with the Medical Evaluations lead to support PV process and data consistency by establishing and maintaining job aides and supporting standards/conventions documents e.g. data entry conventions, coding conventions/standards, case assessment conventions
  • Support Development Training Team in in the preparation of PV training materials and ensure that, the relevant training is assigned to PV Seqirus staff, and other stakeholders as appropriate.
  • Conduct impact assessment on PV documentation (SOPs, WIs, conventions documents) with changes in process, regulation, and systems
  • Support PV process improvement, CAPA implementation initiatives and leading documentation update efforts for the impacted documents
  • Support alignment of applicable local procedures with global procedures in close collaboration with the Regions Lead

Scope/Accountability:

  • Global responsibility for Seqirus Pharmacovigilance SOPs/WIs/Conventions and Standards documents
  • Ensure compliance to regulations and company polices via alignment of documentation

Impact/Influence/Liaison:

  • Design and implement Innovative, efficient business processes to enable pharmacovigilance compliance
  • Establish the most effective supporting documentation needed by PV to drive consistency and quality in the business process
  • Rapidly adapt and implement regulatory changes

Key Relationships:

  • Main Internal Stakeholders: Benefit Risk Physicians, safety scientists, compliance manager, PV Systems Lead, and interfacing functions such as Regulatory Affairs, Quality, Medical Affairs, Legal.
  • External: Seqirus vendors e.g. CROs

Decision Making:

  • Ensure resolution of business process issues/gaps/improvements and clear documentation of to-be process as well as roles & responsibilities
  • Ensure escalation and communication of PV Compliance and quality issues to PV management

Innovation:

  • Ensure quality and robust processes and documentation allowing best operational support to the production of quality safety reports (individual or aggregate)
  • Ensure seamless communication between CROs and PV Ops

Knowledge, Skills & Competencies:

  • Strong communicator with excellent English language skills, both written and spoken, ideally demonstrable experience in a medical/scientific writing.
  • Excellent negotiation, conflict resolution, decision making, problem solving, and presentation skills

Minimum Education/Experience Requirements:

  • Higher education degree in a scientific field
  • Minimum of 5 (preferably 7 years) in Pharmacovigilance and/or clinical research/clinical safety experience in the pharmaceutical environment
  • Significant experience with SOP authoring and documentation management
  • Expertise in international regulations
  • Significant experience with and demonstrated success in working on global cross-functional diverse teams;
  • Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills

Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

 

 

 


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