Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.
Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.
Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.
Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Professional for the Pharmacovigilance department at our Marousi premises.
As a Pharmacovigilance Professional the ideal candidate will be responsible for day to day performance of PV tasks as per GVP & global safety requirements
More particularly:
What you will do:
- Maintain awareness of global (EU, US and ROW) pharmacovigilance regulations and guidelines
- Handle adverse event reports (ICSRs, SUSARs), i.e., receipt, database entry, processing and timely reporting to relevant authorities/stakeholders
- Ensure completeness, consistency and pro-actively approach reporting individuals for missing or inconsistent data and ensures adequate and timely follow-up
- Be responsible for screening of scientific / medical literature to identify reports on adverse events or other important safety information on assigned products
- Assist in reconciliation activities as per company’s standard procedures (SOPs) and/or as per signed Pharmacovigilance Agreements
- Write aggregate reports for assigned products (i.e. Periodic Safety Update Reports, Development Safety Update Reports, Addendums to Clinical Overviews, Annual Safety Reports)
- Prepare Risk Management Plans (RMPs) & participates in the implementation of risk management activities
- Contribute to quality records preparation, PSMF maintenance
- Contribute to Signal Management process
- Upload information on assigned products to the Art 57(2) database
- Monitor safety announcements, National Competent Authorities websites and the EMA website to ensure that documentation on product safety information is kept up to date & communication of such safety announcements to the concerned stakeholders
- Update or compilation of pharmacovigilance standard operating procedures (SOPs) and other quality-controlled documentation regarding PV system operations
- Interact with clients, affiliate and other stakeholders that are related to the duties of the described position
- Handle Medical Information Enquiries (MIEs), as appropriate
- Assist in pharmacovigilance audits and inspections
Requirements
The ideal candidate should have:
- Master’s / Bachelor’s Degree in Life Sciences or equivalent
- 1-3 years of pharmacovigilance experience within a pharmaceutical industry or consultancy environment
- Previous experience in EudraVigilance environment and safety databases would be considered an asset
- Fluency in English
Job-Specific Skills:
- Excellent communication skills both writing and speaking
- Good level of computer literacy
- Highly flexible, adaptable and experienced in fast – paced working environment
- Ability to work on multiple projects and prioritize tasks; excellent time management and problem solving skills
- Ability to work accurately with close attention to detail
- Strong organizational skills
Benefits
What you'll gain:
- Involvement in a high-caliber, team-oriented and dynamic atmosphere
- Exposure to challenging business issues and practices
- Great opportunity to leverage and develop your business knowledge and skills
Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.
Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.
