Senior Safety Services Specialist

642

Workplace Type: Remote

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.

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
• Analyzes subject medical records and write SAE/UADE and case summaries
• 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.
• Experience - Minimum six years of drug safety/pharmacovigilance experience and experience writing narratives and critical medical review of AEs/SAEs, previous case processing experience in clinical trials. Experience in applying European pharmacovigilance regulations
• 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.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, 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 Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.