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Job Details

Medical Director, Pharmacovigilance

Company: Zest Scientific
Location: Reading
Reference: 2968
Closing Date: 14 Mar 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Are you a Pharmacovigilance or Drug Safety focussed Medical professional with EU QPPV experience? Are you interested in new roles in the Reading, Slough or Maidenhead area? Our client, one of the world's largest and leading CROs is looking to fill their exciting Medical Director of Pharmacovigilance position based in Reading.

Requirements:

Are you a Pharmacovigilance or Drug Safety focussed Medical professional with EU QPPV experience? Are you interested in new roles in the Reading, Slough or Maidenhead area? Our client, one of the world’s largest and leading CROs is looking to fill their exciting Medical Director of Pharmacovigilance position based in Reading.



The key to the success of an applicant for this fantastic opportunity with a leader in the field will lie in their ability to demonstrate a sound background of Pharmacovigilance in a Pharmaceutical, Biotechnology, CRO or Consultancy environment.



The candidate:

* Medically qualified professional (preferably in Internal/General Medicine. Other specialisations will be considered)
* Past QPPV experience (CRO/Consultancy experience preferable but not essential)
* Post marketing PV experience
* Proven input to Signal Detection plans
* An understanding and ability to formulate Risk Management Plans
* Knowledge of Safety reporting requirements and processes
* Past responsibility of the Medical Reviews of ICSR
* Experience working as a Medical professional working in a hospital setting
* Previous positions may include: Associate Director of Pharmacovigilance, Director of Pharmacovigilance, Head of Pharmacovigilance, and Medical Director Etc.



The Role:

* General responsibilities associated with EU QPPV position
* Review and approve the Pharmacovigilance Trial Master file (PSMF)
* Ensure compliance and timely submission of Individual Case Safety Reports (ICSR)
* Review Periodic Benefit Risk Evaluation Reports (PBER)
* Review Period Safety Upgrade Reports (PSUR)
* Review and give input for signal detection plans and activities
* Provide input for European Risk Management Plan (EU-RMP)
* Provide input to Investigator Brochure (IB) and Summary of Product Characteristics (SmPC)
* Provide oversight for Product Information, Labelling and Safety Variations
* Have a direct role in the review and sign off of protocols for post-authorisation safety studies in the EU
* Act as the single point of contact for Pharmacovigilance for the competent authorities and for pharmacovigilance inspections
* Line management responsibility



The company:

* An innovative, highly established and respected CRO providing clinical services to the Pharmaceutical and Biotechnology Markets
* A solid history of successful worldwide Drug Development with numerous successful marketed drugs over varied therapy areas



Salary:

* In order to secure the services of the best talent in the sector, our client is willing to be flexible on package.
* Salary will be commensurate with experience.

Zest is working to a strict deadline on this position, so please apply now and your application will be reviewed immediately.

Apply for this job: Medical Director, Pharmacovigilance

Contact Information:

Address:  Head Office
Globe Works, Penistone Road, Sheffield
S6 3AE
England
Tel:  0114 238 0012
Website:  Visit Our Web Site

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