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Freelance Clinical Project Safety Specialist, Germany - L

Employer
CROMSOURCE
Location
Germany
Salary
Competitive
Start date
6 Dec 2022
Closing date
13 Dec 2022

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Job Details

Description:
Location: Germany - home-based

Schedule: Freelance - 1.0 FTE

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Freelance Clinical Project Safety Specialist to join one of our sponsors in Germany, to join one of our clients, one of the most innovative sciences/pharmaceutical companies in the world.

CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with their client counterparts.

Main Job Tasks and Responsibilities:
  • Complies with the requirements of the company Trial Master File (TMF), including the company Sponsor Oversight File (SOF), per the study-specific TMF plan
  • Attends regular meetings with Vendors and project management to ensure project goals and milestones are being met about safety. Where milestones and objectives are not met, escalating to the functional manager
  • Responsible for the distribution and tracking of safety documents including the creation and maintenance of trackers
  • Prepares relevant study-specific file notes and clarification memos
  • Maintains the safety mailbox ensuring compliance with communication and study plans, ensuring emails are filed in the correct folders and monitored for incoming adverse events
  • Schedules and coordinates study meetings, materials, and agendas and distributes decisions, actions, and minutes
  • Maintaining the Safety SharePoint sites with relevant safety information
  • Responsible for developing training materials for phoneline testing activities. Assist in the development of training materials relevant to the function.
  • Supports in maintaining an up-to-date Argus User Guide ensuring that all users are trained appropriately.
  • Responsible for coordinating safety communications and updates both internally and externally
  • Supports in approval of safety-related invoices
  • Supports the set-up and maintenance of the Safety Database, including relevant plans and user acceptance testing for initial set-up and updates to the system
  • Monitoring the quality of data and processing of SAE cases
  • Monitor the safety database activities and escalate any non-compliance with timelines or processes
  • Assists with the review and maintenance of all Safety Plans. Creation of plans where this is required.
  • Trusted Deputy for EudraVigilance
  • Supports the implementation of coding dictionary updates as required
  • Drug Safety and vendor oversight responsibilities as delegated by the Drug Safety Oversight Team
  • Support in the management of designated contracts by company QMS requirements (as defined in SOP-GEN522)
  • Conducts all job-related activities according to regulatory requirements, global guidelines, and company QMS
  • Support in the assessment of satisfactory delivery of sub-contracted services


Education, Experience, and Skills:
  • Preferably degree educated (science, pharmacy, or health-related discipline preferred)
  • A pharmacovigilance case processing background is essential
  • Experience working with large/comeback datasets is essential
  • General administration experience
  • Clinical Research background is desirable
  • Life Sciences background desirable
  • Excellent time management skills and ability to multi-task and prioritize work
  • Attention to detail and problem-solving skills
  • English excellent written and verbal communication skills
  • Strong organizational and planning skills
  • Knowledge of medical terminology
  • Proven in MS Office products especially MS Excel
  • Trained in GDPR and GPvP
  • Trained in the use of the Argus Database
  • Trained in the use of Eudravigilance
  • Trained in the use of MedDRA and WHODrug Coding


The Application Process

Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

About TalentSource Life Sciences

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 continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Project Safety Specialist, Pharmacovigilance, SAE, Safety Specialist, Database, TMF, Argus, Freelance, FL, Contract, Temporary, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

Skills: Drug Safety Manager, Freelance, CRO, Drug Safety, SAE, English Location: Germany Share:

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Company

CROMSOURCE is an ISO-certified international provider of fully outsourced services to the pharmaceutical, biotechnology and medical device industries, specialised in clinical development and flexible resourcing solutions. CROMSOURCE was founded in 1997 and its successful growth has been built on stability, integrity, and high levels of customer satisfaction. We have grown steadily through offices across all regions of Europe and North America and delivering a comprehensive breadth of services.

Acting through PharmaceuticalMedical Device and Flexible Resourcing Solutions teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development programme, through to provision of full services to a pharmaceutical company performing an international mega-trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.

We are experts providing experts and we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commit to deliver those services on time and within budget – according to our End-to-End Guarantee and this commitment to guaranteed delivery is unique in the clinical research environment.

Find Us
Website
Telephone
+44 (0) 1786 468990
Location
6-9 The Square
Stockley Park
Hayes
Uxbridge
UB11 1FW
GB
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