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Safety Systems Project Lead (m/f/x)

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CSL

25d ago

  • Job
    Full-time
    Senior & Expert Level
  • Research & Development
    Healthcare
  • Melbourne

AI generated summary

  • You must have a relevant Bachelor's/Master's degree, 8-10 years in pharmacovigilance, 6+ years in leadership, expert knowledge of regulations, and experience with inspections and project management.
  • You will oversee pharmacovigilance compliance, manage signal detection, optimize processes, support audits, develop analytical outputs, and ensure efficient reporting and data visualization.

Requirements

  • Bachelor degree, Medical Documentation, or equivalent in a life science discipline or Masters (or international equivalent) in science, medicine/health sciences, or epidemiology; or Bachelor degree (or international equivalent) in science, medicine/health sciences, or epidemiology with an increased experience requirement of an additional 3 years industry experience in a related role.
  • 8-10 years' Pharmacovigilance experience in multinational pharmaceutical industry.
  • 6+ years' experience in a leadership role.
  • Expert knowledge of national/international pharmacovigilance regulations and PV processes.
  • Knowledge of local/international relevant GxP regulations, IT standards and other relevant legislations such as legislations related to privacy protection.
  • Experience with regulatory inspections, administration of complex data sets, project-managing CAPA and SOP development, GxP, and relevant software applications.

Responsibilities

  • Oversees evolving pharmacovigilance legislations and provides strategic direction for implementation of required changes to the global PV system; this may involve cross-functional approaches, including multiple interface functions.
  • Establishes and ensures maintenance of regulatory required documents such as the PSMF, in line with international regulations, guidelines and internal standards.
  • Supports the preparation and conduct of PV inspections and audits, as required and organizes or supports the back-office for regulatory PV inspections.
  • Oversees/leads signal detection and management processes.
  • Implements pharmacovigilance processes and ensures the uniform and timely analysis of safety data.
  • Leads or contributes important initiatives to write new processes, or improve/optimize current processes in the functional area; acts as an expert on cross-functional teams for process optimization.
  • Provides day-to-day management support and direction to direct reports within the functional area.
  • Contributes to study activities or post-marketing activities involving safety data and analysis.
  • Develops and provides advanced analytical outputs to global teams to support analyses and decision making based on safety data.
  • Development of new or enhancement of existing standard reports per company BT quality standards.
  • Gathers, details, and documents user requirements in a way that is useful and meaningful to their business area experts and the technical team implementing the solution.
  • Analyzes impact from changes to the database or changes in user/reporting requirements and provide guidance for vendors.
  • Directs transfer of business requirements into technical solutions.
  • Explores, analyzes and introduces data visualization tools to make complex analyses accessible to a broad audience.
  • Business Process and/or Inspection SME/Leads for areas of responsibility.
  • Provide support related to adverse event reports and ICSR compliance.

FAQs

What is the job title for this position?

The job title is Safety Systems Project Lead (m/f/x).

What are the main responsibilities of the Safety Systems Project Lead?

The main responsibilities include overseeing pharmacovigilance legislations, maintaining regulatory documents, supporting PV inspections and audits, leading signal detection processes, implementing pharmacovigilance processes, and developing advanced analytical outputs.

What qualifications are required for this role?

A Bachelor's degree in a life science discipline or a Master's degree in science, medicine/health sciences, or epidemiology is required, along with 8-10 years of pharmacovigilance experience in the multinational pharmaceutical industry and 6+ years in a leadership role.

What kind of experience is sought for this position?

The candidate should have 8-10 years of pharmacovigilance experience, particularly in the multinational pharmaceutical industry, along with expertise in national/international regulations and PV processes.

What benefits does CSL Behring offer?

Benefits include excellent income potential, extended benefits, two additional leave days for personal well-being, family services such as psychological support and legal advice, and hybrid working models.

How can I apply for this position?

You can apply online with your CV, certifications, and salary expectation.

What does CSL Behring specialize in?

CSL Behring specializes in developing high-quality medicines that treat people with rare and serious diseases, focusing on areas such as immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas.

Does CSL Behring promote diversity and inclusion?

Yes, CSL Behring embraces diversity and inclusion as part of its global organizational values and aims to reflect the world around us.

Is prior experience with regulatory inspections necessary?

Yes, experience with regulatory inspections is required for this role.

What does the position entail regarding data analysis?

The position involves implementing pharmacovigilance processes, analyzing safety data, developing analytical outputs, and exploring data visualization tools to present analyses in an accessible manner.

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CSL

Science & Healthcare
Industry
10,001+
Employees
1916
Founded Year

Mission & Purpose

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.