Safety Officer - Greece

Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.

We take an one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya’s vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique projects.

Exceya is looking for collaborating with a Safety Officer (Pharmacovigilance), for a full time position, based in Greece. Excellent knowledge of English language is required for this role.

Responsibilities:

Performs as Local Contact Person responsible for Pharmacovigilance.
Performs local literature search/review or quality control on results, maintain local journal/conference lists.
Handles case reports, complaints, queries (from collection to reporting to Client/Authorities).
Prepares aggregate reports (e.g. PSURs/PBRERs).
Prepares Risk Management Plans (RMP).
Assists in handling/monitoring additional risk minimization activities.
Handles communication with external stakeholders (Clients, regulators, local collaborators etc.).
Submits or assists with submission of vigilance related documents and reports.
Working in other aspects of product safety (e.g. PV system maintenance).

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Skills:

Medical Doctor, Licensed Healthcare professional, Pharmacist, Health or Life Science graduate or relevant degree.
Relative experience at least 1 year in pharmacovigilance, regulatory affairs, medical communications and/or clinical research is an asset.
Meeting the local/national requirements for performing as local responsible/contact/qualified person (or back-up/deputy) for product’s safety (pharmacovigilance or medical device vigilance or cosmetovigilance or as applicable relevant to product’s safety) vigilance.
MS Outlook, Word, Excel, Power Point literate.
Good organization and communication skills, sense of responsibility and confidentiality, ability in handling documents/trackers, attention to detail, ability to multi-task, team player, self-motivated and able to work both independently and within teams an ability to perform as trainer.
Fluency in English.