Manager, Pharmacovigilance (PV/Drug Safety) - Medical Devices
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POST DATE 9/2/2016
END DATE 10/18/2016
JOB DESCRIPTIONMANAGER, PHARMACOVIGILANCE (PV/DRUG SAFETY) - MEDICAL DEVICES
Manager, Pharmacovigilance (PV) Medical Device
(home or office based position)
The Manager, Pharmacovigilance is responsible for providing budgetary, operational, and personnel leadership for a team of Pharmacovigilance staff. Oversee implementation of Chiltern Pharmacovigilance procedures. Ensure that reported adverse events meet applicable regulatory timelines.
DUTIES & RESPONSIBILITIES
* Responsible for the selection, training, development, and performance management for a team of Pharmacovigilance staff
* Assign responsibilities to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business
* Support Business Development efforts with new and revised projects. Interact independently with Sponsors not directly involved in their projects and to assist in wider departmental tasks. Represent the department at face to face meetings.
* Oversee development of project-specific Pharmacovigilance budgets and proposals
* Ensure Safety Management Plans and the safety database are adequately prepared for projects
* Perform the following, in conjunction with the sponsor: advise on pharmacovigilance aspects of a study; write or advise on pharmacovigilance sections for protocols and other documents
* Partner with sponsor or Chiltern Medical team to address issues arising from adverse events reported to Pharmacovigilance
* We require a 4 year or equivalent college degree from an appropriately accredited institution, preferably life sciences or Nursing.
* Minimum 2+ years of device experience within a Safety/Pharmacovigilance department.
* Minimum 1 - 2 + years of experience managing a team, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
* Extensive experience in Pharmaceutical or CRO industry, including line management
* Extensive knowledge of global pharmacovigilance/drug safety for clinical trials and licensed products
* Demonstrated ability to conduct pharmacovigilance activities effectively, efficiently and with the minimum of supervision
Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
depends upon experience
Email Michelle Gerardi