Reference: JT - 899349
Closing Date: 11 Feb 17
Salary (£): On Application
Chiltern is looking to recruit an experienced Manager for a full time or Part time (3-5 days per week), permanent position. Ideally the Manager will be office-based Slough, however up to 2 days per week home-based will be considered also be considered. The Manager will be responsible for a wide variety of duties within our well established group. Applicants should have proven experience within management and Pharmacovigilance.
About the company:
Chiltern is the leading, global mid-sized contract research organization. We listen to client needs to deliver customized clinical development solutions with a team of more than 4,700 working across 47 countries to provide comprehensive, yet flexible and responsive, services. Our specialties include clinical development, Oncology, Devices and Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision.
• To attend all relevant study meetings and management meetings
• To help Pharmacovigilance Officers comply with regulations and timelines associated with reporting SAEs to Regulatory Authorities, Ethics Committees and Investigators
• To participate in training sessions and workshops
• To represent the Pharmacovigilance department within the company
• Responsible for the selection, training, development, and performance management for a team of Pharmacovigilance staff located in various locations
• Assist in the development of processes and preparation of SOPs
• 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 efficient processes for the intake and triage of safety reports
• Ensure compliance metrics are maintained for the team
• Ensure that they, and/ or their respective teams, provide the counsel and subject matter expertise to other Chiltern departments
• Perform other duties as required by the Department
A full job description is available
• Minimum 1 to 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.
• Full understanding of the principles of ICH GCP and regulatory requirements
• Ability to maintain confidentiality of data and information during interactions with staff at all levels
• Demonstrated ability to conduct pharmacovigilance activities effectively, efficiently and with the minimum of supervision
• Bachelor’s degree in Life Sciences or related discipline
• Post-graduate degree in Life Sciences preferred
• Good computer literacy with working knowledge of Windows and Microsoft Office applications
• Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English
For more information about Chiltern International, please visit our web site at www.chiltern.com
If you feel you meet the above requirements then please send your CV and covering letter to firstname.lastname@example.org
Please note that if your experience does not mirror that of our requirements for this role you may not receive a response
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
|Website:||Visit Our Web Site|
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