Drug Safety Associate II

Job title: Drug Safety Associate II

Location: Maidenhead - Hybrid (2-3 days per week in the office)

Contract length: 18 month initial contract

Randstad Sourceright, a leading provider of RPO & MSP Recruitment Services are currently recruiting for a Drug Safety Associate II / Pharmacovigilance Specialist on behalf of a global biotechnology company in their Safety and Benefit Risk Management (SABR) business unit. This role is an initial 18 month contract to be based in their Maidenhead offices on a hybrid basis.

The Safety Associate II will be a supporting member of the Global Case Management (GCM)/International Pharmacovigilance (IPV) group who performs daily monitoring of expedited submissions and implementation of the overarching Pharmacovigilance (PV) operations as it relates to the businesses Partners, Distributors (International Partner Markets [IPM]), Vendors and the wider PV network that includes stakeholders worldwide and other functional groups including but not limited to Worldwide Medical, Commercial, Quality, Regulatory and Global Marketing.

Responsibilities:

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  Contributes to oversight of Partners, Distributors, Vendors, including metrics, and review of IPM trackers.

  
  


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  Supports the Organised Data Collection Programs (ODCPs) process for AE collection to ensure consistency with regulations and with departmental goals and objectives.

  
  


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  Supports the collection, analysis, communication, and operational change management process for Regulatory Intelligence related to PV in the Distributor Network.

  
  


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  Delivers training, as required, to the Distributor Network employees using a variety of instructional techniques and modalities.

  
  


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  Monitors on-time training completion and follow-up with Distributor Network employees, as applicable.

  
  


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  Prepares data for Distributor Network quarterly meetings and follow-up of action items.

  
  


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  Performs administrative tasks such as:

  
  
  
  
  
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    Attend routine PV meetings for training purposes and ensure compliance with all assigned training.

    
    
  
  
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    Produce regular and ad hoc reports to ensure compliance to KPIs.

    
    
  
  
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    Investigate and address compliance issues.

    
    
  
  
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    Other and document training requirements from meetings and feedback.

    
    
  
  
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    Perform ongoing day to day tasks including coordination of training services, reconciliation activities, maintenance of meeting minutes and any other ad hoc projects/activities assigned to meet evolving business needs.

    
    
  
  
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    Review queries and coordinate responses related to activities performed by the Distributor Network.

    
    
  
  
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    Adhere to local policies related to flexible working.

    
    
  
  
  
  


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  Supports IPM leadership in the development and ongoing management of technology solutions used to complement the oversight and day-to-today PV activities conducted across the Distributor network.

  
  


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  Contributes to the mechanisms needed to oversee appropriate training of case intake procedures and systems to ensure adequate AE collection in the Distributor Network.

  
  


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  Assists with the controlled document management lifecycle, providing input and monitoring of activities governed by Standard Operating Procedures (SOPs), Job Aids, Distribution Agreements (DAs), Regulatory Services and PV Agreements (RSPVAs), R&D Business Processes, Work Instructions, and reporting forms.

  
  


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  Performs case review activities assigned by supervisor to ensure on-time completion of trackers.

  
  


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  Supports audit and inspections including follow-up of open action items and investigations as related to the Distributor Network.

  
  

 Key Skills / Experience Required:

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  Experience of working with electronic learning management systems is preferred.

  
  


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  Experience of working in the Pharmaceutical Industry is preferred.

  
  


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  Experience in drug safety and Pharmacovigilance (PV) is preferred - roles such as Safety Associate / Market Safety Specialist etc. Knowledge of good GVP practices is preferred.

  
  


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  Flexibility to support multiple time-zones is preferred.

  
  


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  A degree in a Science or Healthcare related area is preferred.

  
  


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  Highly motivated and a self-starter.

  
  


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  Good written and verbal communication skills. Good technical writing skills with the ability to produce clear, concise documentation and communications.

  
  


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  Good presentation and analytical skills.

  
  


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  Proficient in use of Microsoft Office suite - in particular MS Excel and Sharepoint

  
  


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  Good understanding of PV activities and processes.

  
  


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  Ability to work effectively both independently and as part of a team.

  
  

We are committed to providing equal employment opportunities and encourage all qualified candidates to apply. While the hiring process may not be expedited, we urge all interested candidates to submit their applications promptly to ensure their consideration.

To apply, please follow the instructions on our application portal. We look forward to receiving your application

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