Fertithera Labs is a fast-growing Greek Pharmaceutical Company with headquarters in Thessaloniki.
Fertithera Labs invites applications from career-oriented professionals for the position of Regulatory and Pharmacovigilance Specialist in Athens, Greece. (starting part time and potentialy full time in the future)
What the job looks like?
Review regulatory documentation related to Module 1 for DCP, MRP and RUP applications in line with the appropriate timelines
Be responsible for the submission of new dossiers, renewals and variations due to dossier updates for existing products, in eCTD format and in compliance with the global regulations in force
Liaise with external Regulatory authorities as required for the successful completion of projects
Liaise with the appropriate departments within the company to collect all necessary information for the submission of pharmaceutical dossiers and product registration
Ensure policies and procedures are properly evaluated, implemented and carried out, safeguarding the compliance of company
Co-ordinate and support licence-in & license-out products, ensuring smooth progress of all procedures
Monitoring the progress of DCP, MRP and RUP and their finalization in a timely and accurate manner
Review and supervision of PV reporting as per regulatory and internal timelines
Conduct database searches, screen and review global/local literature as required
Quality Control/ Review of ICSRs
Prepare and review the Periodic Safety Update Reports (PSUR)
Prepare and review Signal Management Reports
Preparation and review of written procedures
Proposals for improvement of PV procedures/processes
Participation in Audits, Inspections
Advisory/Training role in PSURs, Signal, ICSR assessment
Review of PV legislation updates, documentation, communication and action planning
Perform PV training to employees and partners
Requirements
University degree in a relevant science (Pharmacy, Chemistry, Biochemistry, Biology, etc). A post graduate degree will be considered an asset
At least 2-3 years of experience in the pharmaceutical sector, in the field of Regulatory Affairs and / or Pharmacovigilance
Knowledge and practical understanding of EU and non-EU pharmaceutical legislation, EMA & ICH relevant guidelines
Experience in PSUR (Periodic Safety Update Reports) and MedDRA coding
Experience in Signal Management will be considered as asset
Ability to work collaboratively in a team, and prioritize work in a dynamic and fast changing environment
Strong communication, influencing and problem resolution skills
Strong organization skills and able to meet deadlines
Ability to be adaptive to change, to multitask and give attention to detail
Very good interpersonal skills, analytical thinking and result orientation
Fluency in Greek and English (written and spoken) and computer literacy. Knowledge of any other languages will be considered an asset
Ability to travel abroad if requested
By joining us you can expect:
We are offering an attractive remuneration package (including medical insurance) and a challenging opportunity for professional development.
If you wish to work in a pleasant, modern, professional environment with excellent career opportunities, please submit your CV below.
All applications will be treated with strict confidentiality. Only shortlisted candidates will be contacted.