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20 Mar 2017

Full-TimeGlobal Clinical Safety & Pharmacovigilance Regions Specialist

CSL Limited – Posted by Sarita Majhi Melbourne, Victoria, Australia

Job Description

CSL Limited is a company that fosters a work culture emphasising Superior Performance, Innovation, Integrity, Collaboration and Customer Focus with a commitment to support, train and grow its people. As a genuine leader in the biopharmaceutical industry, CSL is a multinational ASX Listed Company that is actively growing its Australian based manufacturing operations to support global growth. CSL develops, manufactures and markets products to treat and prevent serious human medical conditions and is globally one of the largest manufacturers of plasma-derived therapies.

The Role
The GCSP Regions Specialist is a global position supporting GCSP Regions in all three sites (US, DE, AU) as well as supporting CSLB’s Worldwide Safety Officers Network.

Provide the operational support for the establishment and maintenance of the CSLB GCSP Regions function, to ensure that CSLB GCSP Regions and Safety Officers Network are compliant with Good Pharmacovigilance Practices (GVP), ICH GCP Guidelines, international standards, regulatory requirements, and CSLB policies and procedures. Support the development and implementation of strategy to optimize the cohesiveness of the GCSP Regions and Safety Officers Network in all PV activities and complex global projects within the GCSP Regions organization.

Together with the GCSP Regions Leads, ensure communication and coordinate consistent implementation of GCSP standards, processes and safety risk management activities between GCSP and the Local and Regional Safety Officers (LSOs/RSOs) based in the CSLB Affiliates.

Core Responsibilities

Establishment and maintenance of the CSLB GCSP Safety Officers Network, e.g. :

  • Develop and maintain a communication platform for effective and regular two-way communication between GCSP and the LSOs/RSOs.
  • Support Regions Leads with regards to two-way communication with the LSOs/RSOs network for timely responses and communication, organization of teleconferences/webinars and global LSOs/RSOs meetings, production of written communications and newsletters, as well as the exploration/adoption of novel communication modes to overcome potential geographic/language barriers.
  • Maintain the appropriate documentation such as LSOs/RSOs contact details, Organized Data Collection Systems (ODCS) table for the Pharmacovigilance System Master File (PSMF), and Global PV quality and compliance related documents etc., in liaison with the CSLB Affiliates in the countries and regions.
  • Act as the key contact point for LSOs/RSOs for this system and for wider GCSP personnel, representing the LSOs/RSOs Network.
  • Assist in the development and conduct of GCSP LSO/RSO GVP Gap Analysis Plan, providing clear tasks, deliverables and resource requirements for the LSOs/RSOs network for a defined period.  This is to include working with key stakeholders to understand current/future LSOs/RSOs Network issues, key operational and management requirements.
  • Develop, review, implement relevant LSOs/RSO and GCSP procedural documents in order to meet local and international regulatory requirements in PV reporting and quality control/compliance.

Develop, implement and maintain a GCSP Regions audit/inspection readiness program including a qualification and training system, and as applicable support LSOs/RSO in audits/inspections in cooperation with GCSP Regions Leads and CQA.

  • Ensure that PV audit/inspections actions/CAPAs in the Regions are addressed, and provide support to applicable LSOs/RSO in closing outstanding audit/inspection action items.
  • Perform role of Subject Matter Expert in a PV-Affiliate/Safety Officer System Audits to assure that the local pharmacovigilance activities and responsibilities by LSOs/RSO as part of the global company PV system, are in compliance with globally applicable pharmacovigilance regulations, GVP, and defined company procedures and expectations.
  • Co-ordinate and maintain the LSO/RSO Training Program, including performing LSO/RSO PV training as required (onboarding training of new LSO/RSO, refresher training, ad-hoc training as applicable).

Position Qualifications and Experience Requirements

Education/Experience:

  • Bachelor’s degree (e.g. in the biological, nursing, healthcare or pharmaceutical sciences, quality or economics) or equivalent
  • At least 5+ years experience in the Pharmaceutical or Biotech industry, preferably within Pharmacovigilance.

Applications must address the selection criteria above and include a current CV and covering letter.
Applications close AEST 7 April 2017.

Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications and other relevant checks form part of the candidate suitability evaluation process.

 

How to Apply

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Job Categories: science and technology. Job Types: Full-Time. Job Tags: Australia and jobs in australia. Salaries: Negotiable.

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