Closing Date: 24 Jan 17
Type: Full Time
Salary (£): On Application
Roche is a global leader in pharmaceutical research and in order to uphold our high standards and commitment to delivery in respect to drug safety, we are looking to develop our Pharmacovigilance team. In this role you will be responsible for submission to the EMA according to European legislation and guidelines; working in collaboration with other functions to resolve E2B failures to maintain quality and compliance of expedited submissions. ...
Roche is a global leader in pharmaceutical research and in order to uphold our high standards and commitment to delivery in respect to drug safety, we are looking to develop our Pharmacovigilance team.
In this role you will be responsible for submission to the EMA according to European legislation and guidelines; working in collaboration with other functions to resolve E2B failures to maintain quality and compliance of expedited submissions. You will be responsible for representing PDS Operations at functional and cross-functional forums.
Working closely with appropriate stakeholders you will use analytical methods to proactively identify areas of potential case processing inconsistency in the safety database and be responsible for preparing Discrete ICSR Package Projects (DIPPs), ensuring that they are tracked to completion. You will help define the strategies and interventions for continuous improvement, providing remediation and driving quality and consistency beyond standard quality control. With understanding of the safety database you will provide business impact assessment to support applicable technical issues and corrective and preventative actions. You will also help maintain the ARIS Suite User Manual to ensure information and guidance is published in a timely manner and co-ordinated in line with any process change.
Who you areYou’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You are a health care professional or hold a life science degree in a related subject with appropriate experience in the Pharmaceutical Industry. You will combine a good knowledge of global Pharmacovigilance regulatory obligations with the ability to evaluate, analyse and interpret data, exercising sound judgement to draw conclusions.
Using initiative and a positive approach to assigned tasks and with proven abilities in managing objectives to an effective conclusion, you can also demonstrate creative problem solving in a complex process-focused environment. Excellent interpersonal and communication skills are essential as you will need to build strong sustainable relationships with internal and external stakeholders across cultures and virtual environments.
Closing date for applications is Friday 27th January 2017.
Who we areOur UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.
UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
|Tel:||+44 1707 36 6000|
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