Company: INC Research
Location: Krakow or Warsaw
Closing Date: 10 Dec 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.
We are currently recruiting a Safety Specialist to be based in Poland, Warsaw or Kraków.
Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance;
Assists in the design and implementation of safety collection, processing, and reporting systems; acts as a primary point of contact for information regarding assigned projects;
Represents Safety and Pharmacovigilance on cross functional teams.
Assists with the workload of other Safety Specialists within the department.
Liaises with Manager or designee with regard to resources, timelines, and issues with quality;
Reorganizes daily workload based on priority; proactively communicates to management new issues; offers solutions and reports availability to take on new assignments.
Trains new staff; acts as the primary resource for other Safety Specialists with regards to answering questions, sharing knowledge and assisting in resolving problems; provides technical support.
Mentors less experienced members of the team.
Assumes responsibilities of safety project leader/endpoint manager for projects which require a team of Safety Specialists, including but not limited to:
a) Assignment of resources and timelines; reorganization of daily workload based on priority
b) Decision making for the project.
c) Proactive communication to management new issues and suggested solutions; and reporting availability to take on new assignments.
d) Development and review of project proposals, budgets, agreements, invoices, financial measures, and performance metrics.
e) Preparation of a Safety Management Plan.
f) Coordination of workload /workflow and coordination of status reviews.
g) Review of project performance metrics (including quality parameters, monthly budget reports, and changes in scope)
h) Approval of invoices.
Manages systems for receipt and tracking adverse event (AE)/endpoint information.
Processes AEs/endpoints according to Standard Operating Procedures (SOPs), and project specific safety plan.
Ensures that all aspects of the Company’s safety data collection and processing are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements; ensures correct study setup and closure including proper documentation and archival.
Trains Investigators and other departments on AE reporting/adjudication.
Delivers presentations regarding safety and pharmacovigilance to internal and external customers.
Provides support to senior departmental management surrounding business development activities, budget, and proposal input, etc., as required.
Maintains current professional knowledge in fields of safety management, coding, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients.
Provides input to senior departmental management regarding ways to ensure adherence to relevant procedures/regulations, ways to improve work efficiency and maintain customer satisfaction.
Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.
Maintains knowledge of ongoing projects and disease-related terminology
Qualifications / Skills and attributes:
BA/BS in Life Science or Registered Nurse/Pharmacist. Moderate experience in Safety and Pharmacovigilance or clinical/clinical research experience or equivalent combination of education and experience. Clinical Research Organization (CRO) experience with therapeutic specialties preferred.
Knowledge of relevant international regulations/guidelines and strong understanding and usage of medical terminology preferred.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet.
Strong organizational, presentation, documentation, analytical, oral/ written (English), and interpersonal skills with strong judgment and tactful discretion appropriate to a professional medical setting.
Ability to make effective decisions, manage multiple priorities, exhibit high degree of accuracy, and meet deadlines in a highly dynamic environment.
Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix 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|
|Website:||Visit Our Web Site|
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