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CHABERTON PROFESSIONALS

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Director Clinical Safety

Pubblicato 101 giorni fa

Introduzione

Descrizione della posizione

 

As Director of Clinical Safety, this is an exciting opportunity to lead and develop a small team within a growing mid-size organization and contribute to the clinical development pipeline.  

 

In this role you are accountable for evaluating emerging clinical safety data and providing recommendations to project teams and SOCs. Furthermore, the role includes providing safety risk management guidance, driving benefit/risk assessments and serving as the Clinical Safety ambassador to business partners, investigators, regulatory agencies and the wider scientific community.  

 

 

Main Tasks and Responsibilities 

 

  • Work in conjunction with VP Clinical Development, set/ adapt the strategy for Clinical Safety management of investigational medicinal products thus ensuring the implementation of appropriate Risk Minimization measures to safeguard trial participants.  

 

  • Oversee and contribute to the activities in Clinical Safety Management including SAE/SUSAR assessments, safety notifications and surveillance, MedDRA coding, global safety database maintenance, signal detection/evaluation and writing of regulatory safety documents and periodic reports (e.g., DSURs, SMPs, SAE reconciliation plans, RMPs, RSIs, etc.)  

 

  • Support the oversight of external vendors used to fulfil clinical safety activities and ensure that they are performing at an appropriate quality and compliance level in line with contracted obligations.  

 

  • Further develop Clinical Safety standard operating procedures in compliance with applicable regulations and guidelines  

 

  • Present safety data to applicable Safety Boards (SOCs) on trial and product level per clinical trial protocols and applicable SOP(s)  

 

  • Act as liaison with partner company’s drug safety team and clinicians to ensure that safety data exchange agreements are in place and regular safety summaries are provided.  

 

  • Educate the organization on critical developments and regulatory guidance related to clinical safety (FDA, EMA, MHRA, PMDA and others)  

 

Requirements needed 

 

 

  • Medical degree (e.g., MD, MBBS) 

 

  • At least 5 years of Clinical Safety including lead functions. 

 

  • High level of medical competence, with an ability to balance this with industry standards. Experience with vaccines or in immunology is preferred.  

 

  • Thorough knowledge of the pharmaceutical industry, especially clinical development and global regulatory requirements and practices governing expedited and periodic safety reporting, signal detection, safety evaluation and risk management activities  

 

  • Excellent written and verbal communication in English  

 

Ref

ANRS-527564

Tipo di impiego

Permanent

Industria

Life Sciences

Ref

ANRS-527564

Tipo di impiego

Permanent

Industria

Life Sciences

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