Safety Monitor Europe

• Performs safety monitoring activities in cooperation with project Medical Monitor or Medical Officer and other relevant project team members.

• Reviews safety events.

• Coordinates the timely completion and submission of required reports to health authorities and business partners
• Maintains ongoing database of SAEs and reconciles SAEs in the database as needed. Reviews adverse events for the study on a regular basis.
• Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.

• Responds to site, Client, pharmaceutical partner requests for information regarding safety in clinical trials (both interventional and non-interventional).
• Participates in DSMB or other safety review committee (SRC) meetings as necessary.
• Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual report, and periodic safety reports.
• Coordinates with project staff.

• Participates in project team meetings for the planning, preparation, and development of all safety-related sections of protocols, study specific safety documents such as Safety Monitoring Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs.
• Contributes to the development and implementation of the safety Case Report Forms (CRF) and Safety Monitoring Plans (SaMP). - Ensures maintaining of documentation required by corporate and project SOPs.

• Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities.
• Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
• Within the assigned projects is accountable for the delivery of complex PV services related to contracted management of Client's PV system, i.e., ensures delivery of PV- postmarketing services as defined in the relevant PvA (Pharmacovigilance Agreement) and/or relevant SOPs.

• Contributes to the negotiation of PvA with Client, ensuring the full PvA compliance with relevant internal and external regulations (e.g., local and European Union (EU) legislation, Client's SOPs, Emmes SOPs, etc.).
• Can be assigned as PV Project Responsible, where acts as a first point of contact for project-level communication with the Client.
• Enforces compliance to the signed PvA, while full adherence to all relevant PV requirements (such as EU and local legislation, Client's SOPs, Emmes SOPs, etc.).
• Ensures that delivery of all PV services, relevant documents and relevant correspondence related to assigned project are properly documented and tracked - in compliance with PvA and relevant SOPs and requirements.
• Ensures that all documentation relevant for the assigned project is always audit/inspection ready.
• Enforces that the delivery of services to the specific Client is regularly monitored and invoiced in a transparent way in full compliance with the relevant contract.
• If appointed National Person Responsible for Pharmacovigilance (NPRP) or Local Person for Pharmacovigilance (LPPV), performs relevant activities in compliance with Good Pharmacovigilance Practice, local and European legislation, Client standard documents, job descriptions and applicable contract; primary point of contact for the relevant national regulatory authority 24/7; monitors and keeps abreast of changes to local PV/Regulatory legislation and published literature regarding safety concerns of relevant medicinal products.
• Represents Emmes in case of audit or inspection directly or indirectly related to the specific PV project.
• Guarantees compliance and adherence to the quality standards.

• Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned, the consistency with GVP, relevant local and international legislation and with requirements of relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA), etc.
• Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures.
• Completes all relevant professional training in the given scope and time frame.
• Practices monthly quality checks.
• Participates in other corporate activities, e.g., corporate safety meetings/activities; annual SOP reviews; cross-department working groups dedicated to improvement of the ways of working and development of innovative solutions and other relevant corporate initiatives.
• Performs other duties as assigned.

• University Degree (e.g., Bachelor's degree), in pharmacology, medicine or nature science preferred.

• The readiness to work in a regulated environment and understanding of the Good "x" Practice (GxP) principles.
• Ability to learn and understand quickly.
• Consistency, quality, compliance and patient centricity respected as key values.
• Excellent clinical judgement and ability to communicate complex clinical issues in a scientifically sound and understandable way.
• Ability to work as a team member and function on across-functional team.
• Ability to direct activities and encourage positive team-based culture.
• Capacity to provide leadership and creativity in the work environment.
• Excellent verbal and written communication skills.
• Fluent in English.

Emmes Global