Drug Safety Officer, Poland - L
- Employer
- ClinChoice
- Location
- Poland
- Salary
- Competitive
- Start date
- 30 Jun 2019
- Closing date
- 30 Jul 2019
View more
- Discipline
- Clinical Research, Drug Safety
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
Description:
Description
Job Title: Drug Sagety Officer (Junior) (f/m)
Location: Warsaw, Poland
Start: ASAP
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Drug Sagety Officer (Junior) to strengthen the team of one of our TOP Pharmaceutical client Companies in Warsaw, Poland.
Main Job Tasks and Responsibilities
To perform and/or oversee the collection, documentation, and processing of adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance
To conduct case follow up with the reporter (including query generation), tracking and exchange with PV centers and CROs
To monitor third party contractor compliance and performance
To perform case/safety information reconciliations with business partners
To conduct literature search and review literature screening search results, identifying case reports and other safety-related findings
To write or contribute to aggregate reports as required
To assist with pharmacovigilance processes and support preparation of SOPs
To assist in product safety review, signal management as required
To actively implement, track and monitor risk minimization measures
To support safety management processes
Education and Experience
Strong communicator and team player with good organizational skills
Requires an understanding of medical and clinical practices, with a strong understanding of medical concepts and terminology
Must have a working knowledge of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
Education in healthcare or life sciences (e.g. pharmacy, nursing, physician assistants, nurse practitioners) preferably at a bachelor level (or comparable local degree) or higher.
Proven track record of 2 years relevant work experience in clinical safety or pharmacovigilance
Preferably familiar with daily clinical and safety database use
Ability to work independently and within a group environment
Computer literate, especially in Microsoft Office, experience with safety database
Excellent written and oral communication skills in English, command of German would be of advantage
If you would like to be considered for this exciting opportunity please send your CV in WORD directly to alexander.sourounis@cromsource.com
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.
Skills: Drug Safety Officer Location: Poland
Description
Job Title: Drug Sagety Officer (Junior) (f/m)
Location: Warsaw, Poland
Start: ASAP
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Drug Sagety Officer (Junior) to strengthen the team of one of our TOP Pharmaceutical client Companies in Warsaw, Poland.
Main Job Tasks and Responsibilities
Education and Experience
If you would like to be considered for this exciting opportunity please send your CV in WORD directly to alexander.sourounis@cromsource.com
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.
Skills: Drug Safety Officer Location: Poland
Company
ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.
We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
Company info
- Website
- https://clinchoice.com/
- Telephone
- +44 1628 566121
- Location
-
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom
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