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Job Details

Pharmacovigilance Business Systems Analyst

Location: United Kingdom
Reference: HQ00001016
Closing Date: 20 Oct 17
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

TalentSource Life Sciences is currently searching for an experienced Business Systems Analyst to work with one of our partner pharmaceutical companies in the Hertfordshire area.     This is a temporary position with TalentSource for 12 months with the possibility of being extended, on a full time basis. The successful candidate will be working on studies dedicated to one client.


TalentSource Life Sciences is currently searching for an experienced Business Systems Analyst to work with one of our partner pharmaceutical companies in the Hertfordshire area.

This is a temporary position with TalentSource for 12 months with the possibility of being extended, on a full time basis. The successful candidate will be working on studies dedicated to one client.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Key Accountabilities:

The Business Systems Analyst will be a key member of the Pharmacovigilance Information Group and will contribute in all aspects to the department's success. The group has overall responsibility for business owned safety systems activities, in particular enabling the exchange of individual case safety reports according to international and local reporting requirements, to Drug Safety Affiliates, health authorities and licensing partners. Other responsibilities include evaluating and implementing technology enhancements to support business processes, maintenance of the business configuration of the systems, as well as implementing and maintaining standard reports. The Business Systems Analyst leverages a combination of business and technical knowledge to contribute to the development, implementation and integration of Drug Safety's business strategies, processes and solutions.

The focus of this position is on the support and administration of the system. Supporting key processes ensure efficient maintenance of the business configuration of the system.

The Business Systems Analyst will provide support to the business owned safety systems, support users, updates and maintenance of the safety database, as well as support UAT writing and executing.


· Provides change management, master data maintenance and front-line application support for applicable Drug Safety systems

· Interacts with Drug Safety functional groups, other information management functions in Development, IT organisations, external business partners, vendors and health authorities

· Creates of reviews requirements, specifications and business process documentation

· Participates in global, cross-functional activities and projects

· Provides support, administration and change management for the Drug Safety systems

· Maintenance of the system's Master Data (i.e. business configuration) such as user account management, regulatory report rules, document templates, protocols, drug dictionaries

· Acts as a process owner for Master Data activities and works closely with the management team to ensure that the process remains effective and works efficiently

· Prepares, delivers and maintains training overview of all new starters

· Performs and documents user acceptance testing on submission rules and associated processes

· Ability to interpret business and regulator reporting requirements to enable system users to comply with current guidelines and plan for future changes

· Works closely with Informatics colleagues to identify and implement technology solutions to meet business requirements

· May be required to travel as appropriate

Education / Qualifications:

· Life Science / Nursing / Pharmacy qualification or other relevant career experience

Experience, Skills & Knowledge:

· Drug Safety / PV experience and knowledge (for example, a case processing background)

· Knowledge of drug safety regulatory obligations and guidelines

· Working knowledge of medical terminologies

· Experience in user acceptance testing

· Working knowledge of industry standard safety systems

· Candidates should have a strong attention to detail. Experience within quality or auditing would be beneficial.

· Computer literacy

· Fluent in English

If you have the experience and are interested in discussing the role for this position, please contact Laura Guascone Consultant, TalentSource Life Sciences Unit,

Why TalentSource Life Sciences/Cromsource?

Cromsource is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Keywords: Drug Safety, DS, Pharmacovigilance, Business Systems Analyst, PV, Business Analyst, Information, Systems

Drug Safety Associate, Drug Safety Officer, Drug Safety Scientist, Pharmacovigilance, Freelance

Apply for this job: Pharmacovigilance Business Systems Analyst

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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