Company: Advanced Clinical Recruitment Ltd
Closing Date: 09 Feb 17
Type: Full Time
Salary (£): Competitive
If you would like to find out more information in regards to this job, please get in touch through either 01142945005 or email me directly at firstname.lastname@example.org.
As a Senior Drug Safety Physician, you will ensure the safety of our products by providing medical analyses and input to meet international regulatory requirements and Company objectives. You will support the VP Pharmacovigilance in increasing the department's effectiveness and profile within the company and support the Qualified Person for Pharmacovigilance in Europe by contributing to the constant improvement of the Pharmacovigilance System.
Key responsibilities will include ensuring high quality, accurate, timely medical contributions to the safety evaluation of products by:
* Leading the therapeutic area team on the preparation of Benefit Risk Assessments,
* The development of proactive risk management strategies for marketed and / or investigational compounds - working closely with Submission teams
* Leading signal detection activities including bringing medical expertise to drive Benefit Risk assessment reports in addition to providing medical review and interpretation of safety data for preparation of aggregate reports such as Periodic Safety Update Reports (PSURs) and
* Ensuring that updated safety profiles of products are provided to senior management
In addition, you will represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be or may be discussed and maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art Pharmacovigilance processes, making recommendations to ensure utmost Role
* Medically qualified physician with post-registration clinical experience and experience within Pharmacovigilance or a related area of clinical development
* Knowledge of regulatory requirements pertaining to Pharmacovigilance in the pre and post approval environments is desirable
* Excellent verbal and written English language, interpersonal, influencing and communication skills
* Demonstrable managerial skills and leadership potential, with the ability to work in a matrix and across international cross-functional teams
* Experience in the use and management of Drug Safety Databases and MedDRA coding and Microsoft Office applications
Regus 2nd Floor
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