CSL - Australia

PV Compliance & Excellence Manager

18 Feb 2021
20 Mar 2021
R & D
Full Time
Contract Type
Experience Level
Experienced (non-manager)
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The PV Compliance & Excellence Manager is part of the Pharmacovigilance (PV) Compliance and Excellence function within PVRM, and involves responsibilities on global, regional, and local levels.

The position is responsible for Supporting compliance in PV processes and procedures, to provide assurance that the Seqirus Pharmacovigilance organisation is compliant with applicable PV regulations and requirements, ICH and GVP guidelines, international standards, relevant regulatory requirements and company policies.

The position holder will work closely with Pharmacovigilance Regional Managers functional areas including local/regional QPPVs, Quality Assurance, the Research and Development (R&D) organisation, and other key stakeholders to define and ensure compliance with global business and regulatory requirements.

Monitoring the Pharmacovigilance System through pre-defined PV Key Performance Indicators (KPIs) and supporting the Pharmacovigilance Leadership Team (PVLT) and local/regional QPPVs with the monitoring and oversight of the Seqirus PV System.

Overseeing and supporting the management of PV-related non-compliance by ensuring that deviations and process errors are recorded and investigated in accordance with Seqirus procedure, and that corrections and corrective/preventive actions are implemented on-time. Also responsible for supporting PVRM deviation/CAPA owners by leading effectiveness checks to ensure the adequacy of implemented CAPAs.

Supporting PVRM in maintaining a constant state of audit/inspection Readiness and partnering to support internal and external audits and regulatory inspections as they pertain to PV by reviewing audit/inspection responses, tracking audit/inspection commitments, and driving on-time CAPA closure.

Ensuring consistency and compliance of PV Business Process against Seqirus standards and regulatory requirements by supporting the preparation and maintenance of PVRM procedural documentation.

Maintaining the Seqirus PV Training System by ensuring adequate PV training is provided to all Seqirus employees and PVRM service providers, and that training compliance is adequately accounted for.

Collaborating with PVRM personnel, cross-functional colleagues, and Seqirus vendors/business partners, with regards to PV quality assurance and compliance issues, as well as recommending/ supporting solutions and compliance related initiatives as required.

Coordinating with PV CQA and other relevant QA functions regarding Key Quality Indicators and PV-relevant Quality Systems, as well as representing PVRM at applicable Quality forums and Quality projects as required

Skills Knowledge and Qualifications:
  • Qualified to full university degree, ideally relating to life sciences, medical, nursing, pharmacy
  • Advantage: Relevant postgraduate qualifications related to PV and/or GVP
  • Significant experience of Pharmacovigilance industry experience with broad overview of all aspects of a PV system.
  • Specific expertise in Pharmacovigilance, Quality or Regulatory Affairs is of particular advantage
  • Proven expertise and understanding of Pharmacovigilance Quality Systems
  • Excellent analytical and process skills and the ability to apply these skills to Seqirus PVRM organization.
  • Global mindset, able to contextualise with a broad, overall view or perspective of an issue or problem
  • Demonstrated ability and experience with PV and/or GCP and/or GMP audits and inspections by Health Authorities (EMA, FDA, etc.)
  • In depth awareness / knowledge of industry regulations and drug safety practices, with emphasis on local and international guidelines
  • Excellent communication, consulting, customer service and problem-solving skills, including relationship with regulators.
  • Strong interpersonal skills and ability to interact with all levels of the organization.
  • Significant Experience with and demonstrated success in working on global cross-functional diverse teams / Ability to work well in a matrix, global team environment.
  • Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills
  • Ability to successfully manage and prioritize multiple critical issues simultaneously.
  • Must be detail oriented, have the ability to meet deadlines.
  • PC skills, including solid knowledge of Pharmacovigilance or Drug Safety Databases are a plus.
  • Excellent time management skills.