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:
Education, Experience, and Skills:
- 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
The Application Process
- 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
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 firstname.lastname@example.org 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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