Pharmacovigilance Aggregate Reporting Specialist, Pharmathen, GR

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 Aggregate Reporting Specialist for the Pharmacovigilance department at our Marousi premises.

As a Pharmacovigilance Aggregate Reporting Specialist 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:

• Compile aggregate reports for assigned products (i.e. Periodic Safety Update Reports (PSURs), Addendums to Clinical Overview (ACOs), Risk Management Plans (RMPs) and other reports) in line with Pharmathen and client needs
• Peer-review of aggregate reports compiled by other members of the PV Aggregate Reporting Team
• Prepare responses to PSUSA and DL/PAR action items
• Collect safety data maintained in the global safety database for inclusion in respective reports
• ·Review already available scientific literature or perform ad hoc screening to identify safety data of concern
• Interface with other functions, clients, affiliates and other stakeholders that are related to the duties of the described position i.e. data collection, submission, exchange
• Support the Pharmacovigilance Compliance Team during PV audits/inspections and other assigned PV compliance tasks
• Maintain archiving of aggregate reporting records up to date
• Maintain awareness of global pharmacovigilance legislative requirements and assess their impact on the company’s Pharmacovigilance System
• Compile or update current pharmacovigilance standard operating procedures and other quality-controlled documentation applicable to PV system operations
• Mentor and train new pharmacovigilance (junior) officers as appropriate
• Compile aggregate reports for assigned products (i.e. Periodic Safety Update Reports (PSURs), Addendums to Clinical Overview (ACOs), Risk Management Plans (RMPs) and other reports) in line with Pharmathen and client needs
• Peer-review of aggregate reports compiled by other members of the PV Aggregate Reporting Team