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Job Details

Head of Medical Safety & Pharmacovigilance

Company: CTC Resourcing Solutions
Location: Basel, Switzerland
Reference: 895515
Closing Date: 18 Sep 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

The Head of Medical Safety & Pharmacovigilance will be responsible for the company’s Pharmacovigilance (PV) system and oversight of all PV-related vendors and activities.

Requirements:

Our client is a privately held Swiss Specialty Pharma company focused on the development of a new kind of drugs addressing different types of diseases, such as new innovative antibiotics to address one of the most pressing emerging medical needs. Thanks to their recent success, they are currently expanding their clinical development activities and CTC is partnering exclusively with them to find a:

 

Head of Medical Safety & Pharmacovigilance

 

Reference Number:         895515-W

Type of placement:         Permanent

Location:                        Basel area, Switzerland

 

Purpose

 

The Head of Medical Safety & Pharmacovigilance will be responsible for the company’s Pharmacovigilance (PV) system and oversight of all PV-related vendors and activities.

 

 

Main Responsibilities
 
Pharmacovigilance:
 

Ensuring that Company’s PV system complies with Company’s obligations as sponsor of clinical trials globally
To assume responsibility for and to ensure  Company’s obligations in relation to Pharmacovigilance are fulfilled 
To work with QA to identify any gaps in the SOP system are identified and filled both for PV vendor management
To ensure that information of any adverse events and suspected adverse reactions reported to Company personnel or to vendors working on behalf of Company, is collected, collated consistently and analysed and is readily accessible
To ensure that Individual Case Safety Reports (ICSRs) from clinical trials, post-marketing use, registries, patient’s named programs and literature are readily and accurately processed, evaluated and reported to the competent health authorities, ethics committee and investigators

 
Medical Safety:
 

  • To understand the safety profile of the company’s products and develop a safety profiling plan
  • To oversee the operation of Company’s independent DSMBs associated with the Clinical Trials
  • To ensure that Development and Periodic Safety Update Reports (DSURs/PSURs), Annual Safety Reports and all other documents providing a comprehensive evaluation of aggregate safety data are prepared, reviewed and submitted to the competent health authorities according to the regulations
  • Provide adequate guidance to the planning and execution of clinical development programs with regard to drug safety-related matters including
  • Proving input into IBs, IMPDs and protocols and development and maintenance of Company’s core safety data sheets and information
  • Ensuring regular and continuous monitoring of safety profile is performed seamlessly
  • Appropriate drug safety quality control and quality assurance procedures are in place
  • Provide input into the preparation of regulatory action in response to emerging safety concerns

 Qualifications and Experience

 

  • Degree in Human Medicine mandatory
  • At least 10 years of experience in all aspects of drug development including Pharmacovigilance and/ or Medical Safety
  • Understanding of GVP and knowledge of global PV regulations and standards
  • Previous experience in setting up and/or overseeing the PV system for an ethical pharmaceutical company would be highly preferred
  • Fluent in both written and spoken English;  German or French is a distinct plus
  • Can-do attitude and entrepreneurial spirit
  • Problem-solver, proactive and detail oriented

 

Apply for this job: Head of Medical Safety & Pharmacovigilance

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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