Descrição do cargoPharmacovigilance Lead - Aggregate Reports Essentials: Degree: Advanced degree in a scientific discipline (eg, life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience. Skills: Benefit Risk / Argus / Aggregate Reports Experience: At least 5 years as a Pharmacovigilance Specialist Location: Remote Europe or Portugal Fluent: C1 or C2 - Fluent English POSITION SUMMARY The Pharmacovigilance Lead Aggregate Reports is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc reporting, and participation in safety meetings for drugs, biologics, devices, vaccines, cosmetics, and/or animal products, according to applicable Standard Operating Procedures (SOP), project specific supporting documents, ICH Good Clinical Practice (ICH GCP), Good Pharmacovigilance Practice (GVP) and all other applicable regulations and standards. The Pharmacovigilance Lead (Aggregate Reports) tasks depend on the process/project/role assigned. ESSENTIAL FUNCTIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions. Essential Functions Statement(s): Demonstrate proficiency in the use of the safety database and associated safety system(s). Demonstrate proficiency with MedDRA and WHODrug coding Integrate scientific expertise with knowledge of safety database functions to ensure accurate and comprehensive case data entry and identification of follow-up requirements for all case types, received from multiple sources, such as spontaneous, clinical trial, post-authorization safety studies, scientific literature, etc Monitors the Client email Inbox, performs review, analysis, triage and filing of safety information within established timeframes Processes safety information in relevant computerized system (e.g. PV database): data entry, MedDRA and WHODrug coding, case narrative writing, quality control, reconciliation, as per client specific requirements Ensures quality, compliance and consistency of all steps of case processing activities (case management) Cooperates with the Medical Reviewer to collect all required information and determine AE medical assessment Complete medical literature search activities for pharmacovigilance purposes Complete social media search activities for Client products for pharmacovigilance purposes, if needed Contributes and/or assists in preparation (writing, compilation) of expedited and periodic safety reports (including Suspected Unexpected Serious Adverse Reactions (SUSAR), DSUR, Line listings, IND safety reports) Assistance/writing of aggregate safety reports (PSURs/PBRERs, ADCOs, PADERs etc.), DSURs, risk management plans and signal detection reports Knowledge of regulatory and compliance guidelines to ensure expedited and non-expedited submissions to the appropriate entities Knowledge of regulatory and compliance guidelines to ensure periodic report submission to the appropriate entities Knowledge of regulatory and compliance guidelines to ensure risk management activities are completed and reported within regulatory determined timelines to the appropriate entities Create and review ad-hoc reports from the safety system and associated safety tools Completes Quality Review of periodic reports and ad-hoc reports Completes Quality Review of data retrieved from the safety system and associated safety tools Assisting as member of the safety management team in the determination of whether new safety information requires amendment to Clinical Trials documentation Develops PV documentation including: SOPs, Work Instructions, Safety Management Plans under TLs or PV Quality Manager(PV QM) supervision Ensures that all PV documents are filed according to SOPs and project requirements Effectively communicates with internal and external stakeholders, participates in internal and external team meetings Maintains and develops professional knowledge by participating in internal/external trainings and by self-learning; Shares PV knowledge and expertise with PV team, other departments and Clients, actively promoting patient safety principles and awareness Acts as a mentor and trainer for new PV employees (shares knowledge, performs content quality check, provides support in issue solving) Participate in staff training and other measures to ensure Med Communications International compliance with Client quality guidelines and key performance metrics. Supports the role of the QPPV and interacts as required. Assists in collection, verification and tracking of local and global safety reporting requirements Demonstrate ongoing scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscape. Comply with all applicable guidelines, policies, legal, regulatory, and compliance requirements. Meet or exceed service levels and targets for internal and external customers Work with the PV Team Leader to identify areas of process improvement for processing of incoming data and Client information If required, take responsibility for PV Projects implementation and maintenance, as Implementation Leader(IL) or Team Leader(TL) Coordinates PV activities to ensure timely and adequate distribution of workload for assigned team, as applicable Contributes to overall compliance with project and departmental goals and objectives Identifies, prioritizes, and monitors quality issues to be resolved to maintain compliance Assists during PV audits, inspections and CAPA processing Supports implementation and use of new technologies and solutions, as applicable Reports time and activities performed - according to SOPs and Line Manager requirements Participates in internal initiatives and additional activities (as assigned by Line Manager) Performs other activities/tasks if assigned by Line Manager/PV QM Other pharmacovigilance activities as requested. POSITION QUALIFICATIONS Excellent knowledge of ICH GCP and other ICH/EMA/FDA and local regulations and standards applicable for PV area; Ability to interact with other departments within the company and be proficient in e-mail, written, and verbal communication. Proficient in Microsoft Excel, Power Point and Word and quickly able to learn new software. Demonstrated proficiency in safety systems, such as Oracle Argus Safety, ARISG or SafetyEasy. Ability to apply regulatory and compliance guidelines to content development. Competency Statements Self-Motivated - Ability to be internally inspired to perform 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 perform work accurately and thoroughly. Technical Aptitude - Ability to comprehend complex 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-related 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. SKILLS AND ABILITIES Education: Advanced degree in pharmacy (PharmD preferred), or other life science degree, or relevant, equivalent pharmacovigilance experience. Experience: Minimum of three years related experience. Demonstrated expertise in pharmacovigilance activities with drugs, medical devices, vaccines, and biologics preferred. Computer Skills: Prefer proficiency with Embase, Ovid Medline, PubMed, Microsoft Office products, safety databases such as Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy and content management systems. Other Requirements: Preferred pharmaceutical industry experience including an excellent understanding of global legal, regulatory, and compliance requirements with regards to pharmacovigilance. WORK ENVIRONMENT Remote: Romania / Poland / Portugal or Brazil 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 perform the position described. It is not intended to be construed as an exhaustive list of all 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 perform, as the company may deem appropriate. To apply for this role: Step 1: Proceed to follow the form instructions Step 2: Our HR team will review your application with feedback Step 3: If successful, HR will arrange your Introductory call Step 4: A potential online language assessment Step 5: 1st formal interview Step 6: 2nd formal interview Step 7: Offer NB* To be fully informed, the Job Description will be provided at Step 3 along with further information so that all aspects of the role are covered as much as possible. 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 all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, 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 CVs, as our in-house team manages all hiring processes. Please be aware that any unsolicited CVs 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 reach out to preferred partners proactively. Your understanding and cooperation are appreciated.
