Job Title

THE POSITION: This position supports of the Pharmacovigilance (PV) Department as both a key team member and contributor in the scheduling and development of aggregate safety reports, generation of project and safety or signal report specific line listings, risk management materials, and safety data compilation from clinical trials and spontaneous post-marketing reports and other sources.ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: • Plays an essential role supporting PV Operational Delivery to facilitate and meet client project deadlines for various aggregate and signal reports, line listings, and safety data compilation as required by client. • Manages the operational aspects of aggregate safety reporting. Provides pharmacovigilance data analysis, authoring, and quality control (QC) expertise for the preparation of Periodic Adverse Drug Experience Reports (PADER) • Support drafting of assigned sections of other aggregate reports like Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR) / Periodic Benefit Risk Evaluation Reports (PBRER), Annual SafetyReports (ASR), and IND Annual Reports and client specific signal detection reports. • Generate aggregate reports line listings as required to meet regulatory requirements and contracted deliverables for client projects • Collaborates with various stakeholders to ensure that outputs from the safety database meets the need for preparation through submission of aggregate safety reports, while maintaining compliance with regulatory timeline(s). • Thorough understanding and adherence to aggregate safety reporting processes and procedures, safety management plans (SMP), and safety data exchangeagreement(s) (SDEA) / Pharmacovigilance Agreement(s) (PVA). • Knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis, benefit-risk assessment, drug development, and post-marketing requirements. • Familiar with safety database(s) (e.g., ARGUS, ARISg) and MedDRA. • Strong attention to detail with a proactive persistence approach to following tasks through to completion. • Support PV Operations, PV audits and inspections • Draft other safety writing deliverables as needed. • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. • All other duties as assignedMINIMUM KNOWLEDGE, SKILLS AND ABILITIES: •Broad knowledge of domestic and international drug safety regulations, industry practices and standards •Strong attention to detail, teamwork, and initiative •Strong understanding of drug development, drug safety reporting, as well as anappreciation for the importance of regulatory compliance •Familiarity with FDA and international adverse event reporting regulations per ICH guidelines •Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus •Must be quality oriented and demonstrate consistent attention to detail •Must have the ability to follow established processes and the flexibility to adoptnew practices and priorities as required •Knowledge of relevant software including safety database and Microsoft Office PREFERRED QUALIFICATIONS: •BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred •Positive Attitude and Energy – Exhibits an upbeat attitude, a genuine interest in others, and a sense of humor. Energizes others and heightens morale through her/his attitude. •Communication Skills – Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate. •Innovator – Transforms creative ideas into original solutions that positively impactthe company’s performance. •Highly Principled – Proves to be a professional of unquestionable integrity, credibility, and character who demonstrates high moral and ethical behavior.