Drug Safety Scientist
Remedica
Limassol, Cyprus
Role
We are looking for a Drug Safety Scientist to support and manage our daily Pharmacovigilance operations and elements.
Duties and Responsibilities
Reviews the EV website and other relevant websites for any information regarding new regulations, laws etc.
Performs the worldwide literature search.
Updates the Pharmacovigilance System Master File (PSMF).
Manages Remedica’s Pharmacovigilance System in order to ensure that all information on suspected ADRs, is collected, evaluated and reported to the National Competent Authorities.
Prepares and submits PSURs and RMPs.
Has an overview of medicinal product safety profile (including management of signals).
Prepares and revises agreements with other organizations for the exchange of relevant information.
Submits all information on medicinal products marketed within the European Economic Area in the electronic database (EudraVigilance) of the European Medicines Agency (EMA), and keeps this information up to date.
Participates in Safety Review Meetings, in audits etc.
Participates in educational seminars.
Is aware of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the medicinal products.
Is member of Remedica’s Scientific Advisory Service and performs the duties set out in the relevant Scientific Service internal instructions.
Qualifications, Skills, Experience
BS in Pharmacy or Medicine or Chemistry or Biology or Biomedical Science.
Excellent knowledge of Microsoft Office i.e. Word, Excel, PowerPoint, etc.
Excellent knowledge of the Greek and English languages.
Excellent communication skills.
Trusted, Hardworking, Organised, Ability to work under pressure with minimum supervision.
Experience: For pharmacist or Doctor or Biomedical scientist: Not necessary. For Biologist or Chemist: Minimum 2 years.
Remedica
Limassol, Cyprus
Role
We are looking for a Drug Safety Scientist to support and manage our daily Pharmacovigilance operations and elements.
Duties and Responsibilities
Reviews the EV website and other relevant websites for any information regarding new regulations, laws etc.
Performs the worldwide literature search.
Updates the Pharmacovigilance System Master File (PSMF).
Manages Remedica’s Pharmacovigilance System in order to ensure that all information on suspected ADRs, is collected, evaluated and reported to the National Competent Authorities.
Prepares and submits PSURs and RMPs.
Has an overview of medicinal product safety profile (including management of signals).
Prepares and revises agreements with other organizations for the exchange of relevant information.
Submits all information on medicinal products marketed within the European Economic Area in the electronic database (EudraVigilance) of the European Medicines Agency (EMA), and keeps this information up to date.
Participates in Safety Review Meetings, in audits etc.
Participates in educational seminars.
Is aware of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the medicinal products.
Is member of Remedica’s Scientific Advisory Service and performs the duties set out in the relevant Scientific Service internal instructions.
Qualifications, Skills, Experience
BS in Pharmacy or Medicine or Chemistry or Biology or Biomedical Science.
Excellent knowledge of Microsoft Office i.e. Word, Excel, PowerPoint, etc.
Excellent knowledge of the Greek and English languages.
Excellent communication skills.
Trusted, Hardworking, Organised, Ability to work under pressure with minimum supervision.
Experience: For pharmacist or Doctor or Biomedical scientist: Not necessary. For Biologist or Chemist: Minimum 2 years.
