PPD Sr Safety Reporting Specialist in Mexico
Responsible for the receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues. Leads projects and programs and provides guidance and support to other team members. May also be involved in updates to procedures, regulatory intelligence actvities and other initiatives related to safety reporting. Essential Functions * Receives, prepares and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. * Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines. * Provides input and feedback to aid the development of program and departmental procedural documents. * Shares ideas and suggestions with team members. Takes an active role in the development and implementation of ideas and suggestions. * Liaises with relevant departments around safety reporting tasks and attends various meetings as required. * Provides input, feedback and guidance to other team members and mentors new starters. * Produces metrics and has some involvement in financial project.
Qualifications:Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification.Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, and experience.Knowledge, Skills and Abilities:Excellent knowledge of medical terminologyExcellent Microsoft Office skills and good understanding of database functionalityExcellent knowledge of procedural documents and thorough understanding of global safety reporting requirementsGood time management and multi-tasking skillsStrong attention to detailAbility to influence at all levels of the organizationAbility to work well in a collaborative team environmentDemonstrated initiative and utilizes persuasion and negotiation skillsExcellent critical thinking and problem solving abilitiesAbility to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting activitiesWorking Conditions and Environment:Work is performed in an office/ laboratory and/or a clinical environment.Exposure to biological fluids with potential exposure to infectious organisms.Exposure to electrical office equipment.Personal protective equipment required such as protective eyewear, garments and gloves.Physical Requirements:Ability to work in an upright and /or stationary position for 6-8 hours per day.Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.Frequent mobility required.Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.Ability to access and use a variety of computer software developed both in-house and off-the-shelf.Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.Frequently interacts with others to obtain or relate information to diverse groups.Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.Regular and consistent attendance.Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
Job: *Pharmacovigilance & Drug Safet
Organization: *MX BU
Title: Sr Safety Reporting Specialist
Requisition ID: 205086
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group