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 the second largest influenza vaccine company 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!

In order to strengthen our Emerging Europe organisation, we are currently recruiting for a

Regional Safety and PV Manager (m/f/x) - Cluster: Emerging Europe

to be located in any affiliate within the cluster.

This is a two years fixed term contract.

The position is fully responsible for pharmacovigilance/safety in the Central Eastern European Country Cluster (Emerging Europe, EEU), consistent of 12 countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia, Ireland. The complex and diverse cluster has the ambition to excel a top-line of USD 200m within the current Strat Plan period.

Beside the accountability for pharmacovigilance the incumbent is the deputy for regulatory and quality for the whole cluster, too.

Therefore, the position is the primary interface between the business partners/ CSL Behring affiliates, GCSP, Global Quality Assurance and Global Regulatory Affairs in assigned Cluster territory of EEU for the mentioned countries: Management and MatrixComplexity as to manage external partners (distributors and service agents) as well as stakeholders within country affiliates and Global.

The position is responsible for compliance regarding all internal policies / procedures and local regulations in the field of Pharmacovigilance, Quality Assurance and Regulatory Affairs in the EEU region.

This position will manage and continually develop compliance activities related to Pharmacovigilance and Quality Assurance and monitor Key Performance Indicators (KPIs) for the EEU region in accordance with established standards.

Regional Safety Officer for the Emerging Europe region (RSO EEU)

In close liaison with GCSP, the RSO is responsible for Pharmacovigilance activities in the relevant country/region, including but not limited to
  • PV inspection readiness
  • Local implementation of PV relevant processes: develop, implement and maintain the local/ regional PV system
  • Training of Local Safety Officers, CSL Behring affiliates / rep offices personnel, and business partners/ service providers in the region
  • Close liaison with global and local interface departments, such as but not limited to GCSP, PV QA, Medical Affairs, Regulatory Affairs to ensure local oversight of all safety relevant information
  • Close collaboration with distributors / service providers including responsibilities for reconciliation and timely forwarding of ICSR and control of business partner's GVP compliance
  • Review / approve PV invoices received for outsourced PV activities


Deputy Regional Regulatory Manager for the Emerging Europe region (RRM EEU)

In close liaison with Global Regulatory Affairs (GRA), the deputy RRM supports the RRM in its responsible for regulatory activities in the EEU region including but not limited to
  • Ensure that labeling texts and Package Materials are in compliant with approved regulatory status (in close collaboration with Supply Chain and Area Manager EEU).
  • Support of regulatory activities for CSL Behring products in the EEU region
  • Responsible for collection and communication of local regulatory requirements; keeping GRA informed.
  • Ensure appropriate training of business partners / service providers on adherence to all applicable CSL Behring global procedures
  • Due Diligence process in collaboration with GRA in the selection of qualified regulatory personnel at the distributor/service provider
  • Establishment and maintenance of contractual agreements for Regulatory Affairs services activities in collaboration with GRA
  • Review and initiation of the reimbursement of invoices of regulatory service activities received from Business Partner / Service Provider
  • Management of Change Control processes, e.g. product launches, CAPAs, etc. for the EEU region


Deputy Regional Quality Officer for the Emerging Europe region (RQO EEU)

In close liaison with Global Quality, the deputy RQO will support the RQO in its responsible for Quality Assurance activities in the relevant country/region, including but not limited to
  • Development, Implementation, and maintenance of local or regional Quality Management System as required
  • Create and maintain local SOPs according to the CSL Behring policies and local regulatory requirements
  • Support CSL Behring in the frame of inspections and audits in the region and keep all relevant stakeholders informed of upcoming audits and/or inspections by any Regulatory Authorities / Notified Body in the Territory (e.g. GMP, GDP); Closely liaises with the relevant functions in the preparation and during the conduct of the inspection / audits; this include role of follow-up coordinator and responsibility for CAPA plans
  • Responsible for having Quality Agreements with business partners/ service providers in the EEU region in place; Responsibility for content is shared and discussed with Global Quality and/or the manufacturing sites
  • Having awareness of the issues surrounding falsified/counterfeit medicines, recalls or any requests from Regulatory Authorities in the EEU region
  • Management of any risk measurement to be taken in the EEU region, e.g. recalls, management of potential counterfeit products in the EEU region in cooperation with Supply Chain and Global Quality and/or the manufacturing sites. This includes communication and guidance to all distributor markets and ensuring that products are quarantined or withdrawn from the market and destroyed with appropriate documentation in the country or any other measures implemented as directed by the Global Quality function of the affected site
  • Ensure Training of internal and external partners in accordance with GxP requirements and/or CSL Behring policies/procedures; Provide onboarding of Quality for new employees at the Affiliate
  • Ensure relevant customer complaints (Product Technical Complaints) and deviations are dealt with effectively, informing the manufacturer and/or marketing authorization holder of any product quality/product defect issues according to CSL global procedures; that includes timely communication to business partners/ service providers, healthcare providers or Regulatory Authorities as required case by case
  • Provide a local interface between GCSP and Quality Assurance (QA), ensuring that all PTCs received in the EEU region are monitored by the RSO so that any PTC that also meets the criteria for an ICSR is appropriately handled in accordance with GCSP procedural documentation and with the requirement for PTC
  • Decide on the final disposition of returned, rejected, recalled or falsified products, if required in coordination with product/device manufacturer
  • Tracking of Product returns, temperature deviations, any non-compliance with respect to local requirements
  • Management of Change Control for the EEU region, e.g. product launches, changes to GxP processes, etc.
  • Responsible for the ongoing support for existing quality processes and systems including training (Plateau); document management (GDRS and docNet); TrackWise applications (PTCs, change control, deviation, CAPA, etc.)
  • Facilitate the transport release process between manufacturers and business partners. Ensure records of this process are maintained and filed accordingly.


Cooperation with other functions / departments, e.g. Medical Affairs, Commercial Operations, Logistics, PV QA, etc. (both internal and external) in the Region to support all business activities in the EEU region.

Position Qualifications and Experience Requirements:

  • Ideally 5-10 years' experience in Regulatory Affairs, Quality and Pharmacovigilance areas in an international pharmaceutical company (PV and RA Service Provider) preferably in an above market function (Region or Global)
  • Fluent in English (oral and written) and German, additional languages welcome
  • University degree, ideally PhD
  • Very good communication skills for interaction / cooperation with agents and service provider / business partners.
  • Competency of coordination with different departments / functions - national and international, internal and external.
  • Business process mapping and engineering
  • Collaborates with Global Process Owners and Leaders to define and deliver on expected project deliverables and value.
  • Represents projects for the Affiliate at required internal and external meetings to assure that priorities are communicated and understood, and that progress/delays/issues are reported
  • Team Player
  • International mindset (managing different cultures)
  • Creativity and Knowledge to solve problems
  • Communicative / Good relationship builder and communicator
  • Be able to work under pressure
  • Not afraid of making decisions
  • Global overview with an interest in details
  • High ethical standards as well as personal credibility


Worker Type:
Employee

Worker Sub Type:
Fixed Term (Fixed Term)
Mission
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Regional Safety and PV Manager (m/f/x) - Cluster: Emerging Europe