Senior Safety Monitor

Overview

Senior Safety Monitor

Czech Republic - Prague OR Bratislava, Slovakia

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Reporting to the Therapeutic Area Safety Manager Europe, the Senior Safety Monitor Europe will implement Pharmacovigilance and Medical Monitoring (PMM) activities in collaboration with other members of the PMM. The Senior Safety Monitor Europe will be responsible for safety monitoring for all interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor or Medical Officers and the project team. In addition, Senior Safety Monitor Europe supervises the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers or Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. Senior Safety Monitor Europe supports the adherence to Good Pharmacovigilance Practice (GVP) and to other relevant Pharmacovigilance requirements across Emmes EU organization.

Responsibilities

• Performs safety monitoring activities in cooperation with project Medical Monitor or Medical Officer and other relevant project team members.
• Reviews safety events.
• Oversees the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources - clinical (both interventional and noninterventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc.
• Provides first line evaluation of serious adverse events (SAEs).
• Communicates with site staff regarding reported AEs or SAEs to gather additional information.
• Prepares a summary narrative for each reported SAE suitable for inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
• 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, and 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 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 Standard Operating Procedures (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.
• 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.
• If appointed in specific project as EU Qualified Person for Pharmacovigilance (QPPV), undertakes responsibility for establishing and maintaining the entire pharmacovigilance system in accordance with the EU legislation, GVP and applicable local regulations. This includes but is not limited to the nomination of EU-QPPV Deputy, maintenance of the PV system and its processes together with the applicable SOPs, PV related trainings, signal detection and evaluation of Benefit-Risk of Products, global and local literature monitoring. Supports audits and inspections and communication with the applicable health authority.
• Represents Emmes in case of audit or inspection directly or indirectly related to the specific PV project. 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.
• 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.
• Acts as a mentor for junior colleagues.
• Drives other corporate activities including: development and teaching of Emmes classes, chairing of corporate safety meetings/activities; coordination of annual SOP reviews; coordination of cross-department working groups dedicated to improvement of the ways of working and development of innovative solutions and other relevant corporate activities.
• Performs other duties as assigned.
  
  

Qualifications

• University Degree (Bachelor at minimum), preferably in pharmacology, medicine or nature science.
• Demonstrated 5-8 years' experience in clinical practice, pharmacy, research or pharmaceutical medicine (CRO, SMO, pharma company, etc.) with 3 years' experience in safety monitoring/pharmacovigilance.
• Proven leadership and/or managerial experience, including project management, preferred.
• The ability to independently and responsibly perform assigned pharmacovigilance related tasks in the highest quality - with little or no supervision.
• Excellent clinical judgement and ability to communicate complex clinical issues in a scientifically sound and understandable way.
• Expertise in safety monitoring and serious adverse event reporting.
• Demonstrated experience with or training in clinical trial data collection.
• Ability to work as a team member and function on a cross-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.
  
  

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