Pharmacovigilance Officer

Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.

The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.

Pharmathen's highly diversified portfolio consists of over 90 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.

Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company's enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to 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 Pharmacovigilance Officer for the Pharmacovigilance department at our Maroussi premises.

As a Pharmacovigilance Officer the ideal candidate will be responsible for day to day performance of Pharmacovigilance 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, follow-up and timely reporting to relevant authorities/stakeholders
• Be responsible for screening scientific / medical literature to identify reports on adverse events or other important safety information on assigned products
• Assist in reconciliation activities
• 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   
• Compile or update of pharmacovigilance standard operating procedures (SOPs) and other quality-controlled documentation regarding PV system operations
• Interacs with clients, affiliates 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
• Fluency in English
• 1-3 years of pharmacovigilance experience within a pharmaceutical industry or consultancy environment
• Previous experience in EudraVigilance environment and safety databases preferred

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.