Operating for over two decades in Greece and Cyprus, CORONIS has been delivering a full spectrum of services to national and international pharmaceutical, biotechnology and medical device industries and other healthcare-related organisations. As a Contract Research Organization (CRO), CORONIS wishes to contribute to the delivery of life-changing therapies to patients worldwide.
Currently we are looking for a Safety Officer, with experience in managing pharmacovigilance activities in compliance with PV local and international regulations to join our team!
The Safety Officer is responsible for driving our vigilance services to excellence by focusing on quality, safety, timely-delivery, productivity, and diligence for our projects’ needs in pre and post marketing environment.
Primary responsibilities:
- Acting as a single PV point of contact for the regulatory authorities on a 24/7 basis as well as for pharmacovigilance global teams and involved parties
- Managing, processing, reconciliation and reporting of Adverse Events, Individual Case Safety Reports (ICSRs), Product Complaints, other Safety Events and Signals
- Overview of medicinal product safety profiles and any emerging safety concerns
- Maintaining a controlled secure PV system (including PSMF, records, safety-related data, submissions to regulatory authorities)
- Overview and Managing of Risk Management Plans and Educational Materials activities, while cooperating with regulatory department for local implementation and submission processes
- Provide support in the development of medical documentation such as PSUR & DSUR
- Scientific Literature Surveillance and reporting
- Handling of Direct Healthcare Communication
- Liaise with local regulatory authorities and Global PV for safety information requests, response preparation, and submission, while informing competent authorities for any new information relevant to the benefit risk evaluation
- Provide regulatory intelligence to our clients by reviewing and evaluating regulations, guidelines, procedures etc.
- Manage Safety Data Exchange Agreement (SDEA) preparation & updates (including safety plan and workflow mapping)
- Ensure compliance of all projects with local and international PV regulations, GVPs and internal procedures, while handling any non-compliances identified and implementing corrective/preventive actions
- Support the compilation/updates of the Standard Operating Procedures (SOPs)
- Support audits and inspections preparation/readiness
- Contribute to the training of PV and non-PV staff per contractual agreements
Qualifications:
- University Degree and Master’s Degree (or Ph.D. or MD) in life sciences, pharmacology, chemistry or medicine
- 3-5 years of work experience at a pharmaceutical, CRO or biotechnology company
- Minimum 2 years of experience in Pharmacovigilance
- Solid understanding of the drug development process, pharmaceutical legislations and guidelines
- Solid knowledge of PV systems, GVP and ICH-GCP guidelines, as well as local and International PV regulations and medical terminology. Knowledge over medical devices’ regulations and guidelines will be considered a plus
- Excellent organizational and prioritization skills, project and time management as well as ability to develop, plan and successfully complete short and long-range goals
- Advanced critical, strategic thinking and problem-solving skills and ability to take appropriate corrective action
- Excellent command (written and verbal) of English language
- IT literacy (MS Windows, MS Office, Internet Use)
Benefits:
- Competitive renumeration package
- Continuous learning
- Career development opportunities
- A fast-growing, friendly, and social working environment
If you fulfill the requirements of this position and you’re interested in joining our team, please send your CV to: hr@coronis.gr
