Clinical Operations Scientist

3 days ago

Athens, Attica, Greece PharOS Ltd Full time €40,000 - €80,000 per year

Founded in Athens in 2002, PharOS is a privately-owned pharmaceutical Company, developing and supplying generics value added products with a global portfolio. Our expertise covers all aspects of product development from API sourcing up to market release. We provide a broad portfolio of products and intellectual property to leading pharmaceutical companies.

At PharOS, we have a high skilled workforce of more than 400 professionals. Biologists, Chemists, Pharmacists, scientists all focused on developing and placing in the market top quality generic and other value-added pharmaceuticals that improve the lives of patients to more than 98 countries.

Our people are our core competitive advantage that helps us being one of the fastest growing pharmaceutical development companies in Europe. For PharOS our customers, are our partners Our aim is to extend the lifecycle of the product, as our people are able to provide an exceptional level of customer service and support, based on their expertise and professionalism.

PharOS is seeking for a Clinical Operations Scientist within the Clinical Operations department as follows:

Role description

  • Coordinates Bioequivalence / Clinical studies
  • Is the primary point of contact between company and study vendors
  • Monitors and audits activities for clinical studies
  • Reviews Bioequivalence / Clinical study protocols and relevant documentation
  • Assesses Bioequivalence / Clinical studies' data
  • Reviews Bioequivalence / Clinical study reports / Dossier's module 5 and module 2 deliverables
  • Archives and maintains Bioequivalence / Clinical studies related documentation
  • Evaluates the scientific literature related to the clinical aspects (pharmacokinetic and drug metabolism) of the generic pharmaceutical products under development

Experience & Qualification

  • Education to a post-graduate degree level in Pharmacy, Pharmacology, Biology, Pharmacokinetics or similar scientific disciplines
  • One (1) to three (3) years of experience in clinical operations of Generic Pharmaceutical Products is considered as strong asset
  • Knowledge and understanding of ICH/GCP, EU clinical trial regulation and EMA guidelines on the clinical development of generic/non generic products
  • Excellent English oral communication and scientific writing skills
  • Knowledge of CTD Dossier Compilation is preferred
  • Knowledge of medical writing
  • Knowledge of basic pharmacokinetics
  • Experience in the use of statistical/ pharmacokinetic software (for example SAS, WinNonlin etc.) is considered a plus

PharOS Ltd Offers

  • Competitive remuneration package (including bonus based on performance)
  • Private Health & Medical Insurance including a 24/7 support Line
  • Hybrid work-from-home model (3 days office based and 2 days home based)
  • Daily free transportation from/to the Company's HQs to nearby public means of transportation
  • Canteen with discounted prices and daily cooked meals
  • Continuous training
  • Friendly and challenging working environment

PharOS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, or any other basis protected by applicable law, and will not be discriminated against on the basis of disability.

Please note that your resume and any personal information you have provided will be stored in our system for a period of one year, after which it will be deleted.

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