Safety Officer Manager

A leading Contract Research Organization (CRO) is seeking a Safety Officer Manager with experience in managing pharmacovigilance activities in compliance with local and international PV regulations.

The Safety Officer Manager 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
• Over 5 years of work experience at a pharmaceutical, CRO or biotechnology company
• Minimum 4 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)