Senior Safety Specialist
Adecco Personnel Limited
Wan Chai
5天前
source : Jobsearch.hk

Our client, a leading service provider to pharmaceutical, biotechnology and medical device industries, is now looking for a Senior Safety Specialist (Contract) to join their professional team.

Responsibilities :

  • Leading safety data management in case entry, processing (ARGUS) and submission of adverse event reports to the local authority and to Global PhV, as applicable
  • Assists the Lead Local safety officer and Regional PV lead in establishing and maintenance of a local PhV system which includes maintaining understanding of relevant Global and Local SOPs, Work Instructions (WIs), support with maintenance of Local SOPs / WIs and also establishment of local processes to include creation and maintenance of procedural documents
  • Assists in the creation and implementation of the Risk Management Plans (RMP)
  • Local Literature monitoring as required
  • Electronically file all source documents and other safety-related documents according to internal SOPs
  • Maintains awareness and understanding of latest local regulations on drug safety management in the country and assist in providing PhV training to company employees & local 3rd-parties
  • Preparation and submission of reports for local submissions as applicable
  • Liaise with the QPPV to discuss the next steps, actions from and to the local authorities
  • Responsible for PhV activities such as reconciliation and quality checks with internal and external parties
  • Assists in coordination of PhV activities with local distributors to make sure terms from PhV agreements are being followed
  • Assists in executing CAPAs related to PhV audits & inspection findings
  • Contribute in ensuring PV audit and inspection readiness on an operating company level at all times
  • Participation in FMD K&L audits and supporting external audits
  • Maintain organisation level quality standards
  • Timely support to FMD K&L with turnaround as agreed (with data and solutions), preparation of presentations, solutions that result in excellent customer satisfaction
  • Assist in related administrative and procedural activities as and when required
  • Provide support to preparing weekly / monthly metrics with accurate and verifiable data
  • Provide the updated trackers on time to ensure smooth delivery of the project
  • Provide support to lead on daily deliverables and status report updates
  • Create MOM for the meetings and send it to the lead / Operations Head for approval
  • Any other responsibilities that may arise later in time as a part of project requirement
  • Manage the project offshore
  • Preparation of the dashboard and submissions to different stakeholders as required
  • Meeting the project SLAs as agreed with the client
  • Requirements :

  • Master’s Degree OR University Degree in Pharmacy, Life Sciences or equivalent
  • 4+ years’ experience in drug safety with strong understanding of PV regulations and requirements for the designated geography
  • Possess a high level of business ethics, integrity, and professionalism
  • Good communication skills with fluency in English
  • Knowledge of good documentation practices, meticulous and has an eye for detail
  • Self-motivated and has ability to work independently
  • Global mindset, preferably with experience working in a multi-national pharmaceutical company
  • Adaptable to change in a dynamic working environment, able to manage multiple projects
  • Interested parties, please CLICK HERE to apply online.

    Please note that only short-listed candidates will be notified. All information gathered will be treated in strict confidence and solely used for recruitment purposes.

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