Company: INC Research
Location: Warsaw or Krakow
Closing Date: 21 Nov 16
Salary (£): Negotiable
Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development.
Our Safety and Pharmacovigilance service has been one of our core offerings since 1992. We have a global team of experts who can support our customers across all phases of clinical trials and post marketing surveillance ensuring timely collection, analysis and reporting of safety data according to each company’s regulations.
To strengthen this group INC are seeking a Safety Data Coordinator to be based in Poland, Warsaw or Kraków.
•Records all adverse event/endpoint source documentation and tracks them in accordance with sponsor specifications; distributes incoming mail and faxes.
•Redacts patient information/ images in accordance with data protection guidelines and ICH GCPs.
•Performs file creation, tracking, retention, and maintenance (paper and electronic); maintains industry reference documentation.
•Enters data into the safety database/adjudication database in accordance with sponsor specific guidelines and Company standards.
•Ensures current conventions are followed when entering cases into the Safety database.
•Assists with writing non-serious narratives for post-marketing projects as applicable.
•Assists in the distribution of expedited safety reports and periodic reports to sites, Ethics Committees (ECs), Institutional Review Boards (IRBs), and Regulatory/Competent Authorities (RAs/CAs), according to project specific plans.
•Assists with maintaining the SharePoint website for Safety and Pharmacovigilance;
•Escalates issues to management as needed.
•Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.
•Acquires basic understanding and maintains knowledge of ongoing projects and disease-related terminology.
Skills and attributes:
•High School Degree plus nominal clinical research or administrative work experience or equivalent combination of education and experience. Database and medical terminology preferred.
•Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail skills.
•Excellent oral and written communication skills.
•Strong interpersonal and customer service skills appropriate to a professional medical setting.
•Strong organizational and documentation skills.
•Detail oriented with high degree of accuracy.
•Ability to handle multiple tasks and meet deadlines in a dynamic environment.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“INC Research has been ranked as “Top CRO to work with” among large global CROs in the biannual CenterWatch Global Investigative Site Relationship Survey. INC is the only CRO to rank consistently among the top three CROs in all seven CenterWatch site relationship surveys conducted since 2007”.
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
European Head Office
River View, The Meadows Business Park,
|Tel:||+44 (0) 1189 335 300|
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