Pharmacovigilance Aggregate Reporting reputed company

Pharmacovigilance Aggregate Reporting reputed company Position Summary 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 client 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 client teams to deliver submission-ready documents reputed company regulatory deadlines. Essential Functions reputed company and supervise the planning, writing, compilation, quality review and submission of PSURs/PBRERs, DSURs, PADERs, ADCOs, Line Listings for assigned client 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. Integrate signal evaluation outcomes and benefit-risk assessments into periodic safety reports in collaboration with the Signal Management reputed company and medical reviewers. Review and quality-reputed company safety database outputs (line listings, summary tabulations, etc) for inclusion in aggregate reports. Author 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 client 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 Quality 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 actively support QA activities including CAPA follow-up. reputed company with reputed company applicable guidelines, policies, legal, regulatory, and compliance requirements. Education: Advanced degree in life sciences - pharmacy (PharmD), or Medicine(MD) preferred. A postgraduate qualification in regulatory affairs, Pharmacoepidemiology, or drug safety is an advantage. Experience: Minimum 4 years of PV experience, with at least 2 years focused 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, Veeva Safety, AB Cube SafetyEasy), document management systems, reputed company Office Suite (Word, reputed company, Outlook, PowerPoint), literature databases (Embase, PubMed). Familiarity with electronic submission tools and aggregate reporting softwares is an advantage. 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 drive or initiative. Above average attention to detail, teamwork, and initiative. Organized - Possesses the trait of being well 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 specialized 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 find a solution for or to deal proactively with work-reputed company problems. Active Listening - Ability to actively 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 clearly and concisely. Communication, Oral - Ability to communicate effectively with others using the spoken word. Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience.

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Remote: Italy, Romania, Poland or Portugal The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to reputed company the position described. It is not intended to be construed as an exhaustive list of reputed company functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to reputed company, as the company may deem appropriate. Disclaimer By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection. We are an equal opportunity employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national reputed company, age, disability, genetic information, or veteran status. Recruitment Agency Notice: Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited reputed company, as our in-house team manages reputed company hiring processes. Please be aware that any unsolicited reputed company or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy. Should collaboration opportunities arise, we will reputed company out to preferred partners proactively. Your understanding and cooperation are appreciated. Apply To This Job