Senior Safety Services Specialist, Global

vor 3 Wochen

Frankfurt am Main, Deutschland Advanced Clinical Global Vollzeit

Overview:
The Senior Safety Specialist is responsible for ensuring accurate collection, database entry, review, and reporting of clinical trial and post-marketing safety data. They will be required to assist senior staff in signal generation, safety analysis activities, and to be proactive in the development and implementation of departmental processes and guidelines. They will be required to work with clients and project teams to develop Safety Management Plans and Safety-related forms, and to assist with monthly revenue recognition.

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

**Responsibilities**:

- Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
- Performs safety review and analysis of adverse events for clinical studies, including: triage, case review, narrative writing, coding, initial evaluation of listedness/expectedness, query generation, and query tracking.
- Interfaces with medical reviewers, clients and investigator sites on adverse events and other safety-related issues.
- For drugs, ensures compliance with global drug safety regulations, client and/or Advanced Clinical standard operating procedures (SOPs) in all aspects of data processing and reporting of SAEs from clinical trials and other studies, and spontaneously reported SAEs and non-serious adverse events (NSAEs) for marketed products.
- For devices, ensures compliance with global device safety regulations, client and/or Advanced Clinical standard operating procedures (SOPs) in all aspects of data processing and reporting of safety data, particularly for unanticipated adverse device effects (UADEs) from clinical trials performed under an investigational device exemption, and medical device report (MDR) reportable adverse events for marketed devices
- Participates in literature review activities related to adverse event reporting
- Assists with Case Report Form (CRF) review as requested, assessing data provided on CRFs to ensure medical safety and compliance, and generating queries
- Provides mentoring to other staff
- Develops and assists other staff in the development of processes, timelines, planning, and strategy
- Assists with set up and quality control of the safety database
- Is available for some flexible shifts and on-call when needed

Qualifications:

- Education - 6+ years of Pharmacovigilance experience with an RN credentials or above; or equivalent working Pharmacovigilance experience with degree less than RN, such as Bachelor’s degree in healthcare, pharmacy, life science
- Training - Knowledge of Good Clinical Practices (GCPs), FDA, EMA and other global regulations, ICH guidelines, global adverse event (SAE/NSAE) reporting requirements and reporting procedures for clinical trials and marketed products.
- Other - Strong organizational skills; good oral and written communication skills and the ability to articulate issues. Ability to assume a high level of responsibility, ensuring proper reporting of adverse events within the timelines mandated by internal regulatory and client guidelines. Ability to maintain confidentiality. Excellent Microsoft Word and Excel skills.

**At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our**
**mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering ser**
**vices to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priorit

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