Remedica is a leading pharmaceutical company located in Cyprus with pharmaceutical products being distributed in more than 160+ countries worldwide. Originally founded in 1980, it went through various development stages. Today Remedica is specialising in the development, production, and sale of high-quality, safe, and efficacious pharmaceutical products for human use. Our pharmaceutical range consists of a product portfolio of more than 300 generic, branded generic, and over-the-counter (OTC).
Over the last few years, Remedica went through a massive transformational program from a locally recognized reputable company to a global player, respected by its distributors, partners, and clients. The investments into the factories, R&D equipment, new facilities, implementation of best-in-class software, and people development are the baselines for Remedica's success in the future.
We are looking for:
A highly skilled and detail-oriented Senior Drug Safety Scientist to support and manage our daily Pharmacovigilance, Scientific Advisory Service and SFFC operations and elements.
As a Senior Drug Safety Scientist, you will:
- Review the EV website and other relevant websites for any information regarding new regulations, laws etc.,
- Perform the worldwide literature search, Update the Pharmacovigilance System Master File (PSMF), Manage Remedica’s Pharmacovigilance System in order to ensure that all information on suspected ADRs, is collected, evaluated and reported to the National Competent Authorities
- Prepare and submit PSURs and RMPs, have an overview of medicinal product safety profile (including management of signals)
- Prepare and revises agreements with other organizations for the exchange of relevant information, Prepare submit and archive in the EudraVigilance electronic database reports containing information on all authorized medicinal products of the company (XEVPRM), and keep this information up to date
- Participate and schedule audits
- 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 Prepare and send appropriate 'DHPC' letters and educational materials etc.).
- Prepare and evaluate the scientific content of advertising materials and maintain up-to-date records of the latest versions of these advertisements etc.)
- Review the relevant legislation on Serialization and Falsified Medicines, Conduct a daily review of the Alerts Portal of the European Medicines Verification Organization and investigate serialization alerts
- Prepare and review agreements with clients, organizations, etc., for the exchange of serialization information etc.
What you will bring:
- 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.
- Ability to work under pressure with minimum supervision.
- Experience: At least 2 years of experience in a similar position
Why Join Remedica? At Remedica, we offer a competitive compensation package, including 14 salaries, a provident fund, and a range of additional benefits to support your personal and professional growth. Join our team and be part of a company that values innovation, teamwork, and continuous improvement.