Pharmacovigilance Aggregate Reporting reputed company (English)

Pharmacovigilance Aggregate Reporting reputed company Position reputed company The Pharmacovigilance Aggregate Reporting reputed company is a senior expert responsible for leading, coordinating, and overseeing the preparation and submission of aggregate safety reports across assigned reputed company portfolios. The role encompasses the full lifecycle of periodic and aggregate reporting — including PSURs/PBRERs, DSURs, PADERs, ADCOs, and Line Listings, in compliance with EMA GVP Module VII, ICH E2C(reputed company), ICH E2F, and FDA requirements. The role acts as the subject matter expert for aggregate reporting and collaborates with signal management, case processing, medical review, and reputed company teams to reputed company submission-reputed company documents reputed company regulatory deadlines. Essential Functions reputed company and supervise the planning, writing, compilation, reputed company review and submission of PSURs/PBRERs, DSURs, PADERs, ADCOs, Line Listings for assigned reputed company products. reputed company and maintain aggregate reporting timelines and submission schedules, ensuring alignment with IBDs, data lock points and regulatory submission deadlines. Coordinate data collection from reputed company relevant teams to ensure report completeness and accuracy. reputed company signal evaluation reputed company and benefit-risk assessments into periodic safety reports in collaboration with the Signal Management reputed company and medical reviewers. Review and reputed company-reputed company safety database outputs (line listings, reputed company tabulations, etc) for inclusion in aggregate reports. reputed company or reputed company authoring of case narratives, cumulative analyses, and benefit-risk evaluation sections. Manage the review and approval workflow for aggregate reports, coordinating input from medical reviewers, the QPPV and reputed company stakeholders, as appropriate. Contribute to Risk Management Plans (RMPs) and REMS safety sections as required. reputed company, supervise and mentor PV Specialists and Sr. PV Specialists assigned to reputed company aggregate reporting support activities. reputed company and review SOPs, Work Instructions and report templates reputed company to aggregate reporting in collaboration with the PV reputed company Manager. Maintain up-to-date knowledge of global aggregate reporting requirements and proactively communicate regulatory changes to the PV team and clients. Ensure inspection and audit readiness and reputed company support QA activities including CAPA follow-up. reputed company with reputed company applicable guidelines, policies, reputed company, regulatory, and compliance requirements. reputed company degree in life sciences - pharmacy (PharmD), or Medicine(MD) preferred. A postgraduate qualification in regulatory affairs, Pharmacoepidemiology, or drug safety is an reputed company. Experience: Minimum 4 years of PV experience, with at least 2 years reputed company on aggregate/periodic safety report writing at a PV vendor, CRO, or pharmaceutical company. End-to-end PSUR/PBRER experience required; DSURs, PADERs, and RMPs strongly preferred. Computer Skills: Safety databases (like reputed company Argus Safety, ArisG LifeSphere, reputed company Safety, AB reputed company SafetyEasy), document management systems, reputed company Office Suite (Word, reputed company, reputed company, PowerPoint), literature databases (Embase, PubMed). Familiarity with electronic submission tools and aggregate reporting softwares is an reputed company. Competency Statements Self-Motivated - Ability to be internally inspired to reputed company a task to the best of ones ability using his or her own reputed company or initiative. Above average attention to detail, teamwork, and initiative. Organized - Possesses the trait of being reputed company organized or following a systematic method of performing a task. Accuracy - Ability to reputed company work accurately and thoroughly. Technical Aptitude - Ability to comprehend reputed company technical topics and reputed company information. Tactful - Ability to show consideration for and maintain good relations with others. Responsible - Ability to be held accountable or answerable for ones conduct. Problem Solving - Ability to reputed company a solution for or to deal proactively with work-reputed company problems. reputed company Listening - Ability to reputed company attend to, convey, and understand the comments and questions of others. Customer Oriented - Ability to take care of the clients needs while following company procedures. Communication, Written - Ability to communicate in writing reputed company and concisely. Communication, Oral - Ability to communicate effectively with others using the spoken word. reputed company Learning - Ability to participate in needed learning activities in a way that makes the most of reputed company. Work Environment Remote: Romania / Poland or Portugal reputed company has reviewed this job reputed company to ensure that Apply tot his job Apply To this Job