Summarized Purpose : * Responsible for overall planning, co-ordination and delivery of safety reporting for large and complex projects.
Leads complex projects and programs, including full project oversight and maintenance of metrics, compliance, and finances.
Recommends updates to procedures, regulatory intelligence activities and other initiatives related to safety reporting. Provides training and support to other team members and serves as primary point of contact in the absence of the manager. *Essential Functions*
Receives, prepares and submits safety reports to applicable parties, ensuring compliances at all stages.
Identifies and resolves any quality or timeline issues and keeps the Manager informed of progress. Exercises independent judgment to troubleshoot, resolves project issues and identifies areas for improvement.
Leads and monitors large and complex projects effectively to ensure that all aspects of the project are completed sucessfully and on time.
Attends and presents at various meetings as required.
Facilitates and advises on company, client and regulatory audits where required.
Provides training and support to lower-level team members, mentors new starters, provides input on individual performance and shares ideas and suggestions with team members.
Works with the manager to collate metrics, analyzes compliance metrics and provides recommendations on updating financial systems.
Education and Experience : *
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years').
In some cases an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities : *
Advanced knowledge of medical terminology
Excellent Microsoft Office skills and understanding of database functionality
Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements
Excellent critical thinking and problem solving abilities
Demonstrated ability to lead, mentor and motivate others
Ability to work well in a collaborative team environment
Strong attention to detail with ability to work with ambiguity and complexity
Ability to work effectively within a team to attain a shared goal
Demonstrated initiative and utilizes persuasion and negotiation skills to complete assigned tasks, delegating effectively where required
Ability to apply advanced knowledge, skills, and expertize to communicate and assist internal clients / PPD values the health and wellbeing of our employees.
We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment / requirements for this role : /
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.) Job : Pharmacovigilance & Drug Safet* Organization : MX BU* Title : *Principal Safety Report Specialist* Location : *Latin America* Requisition ID : *186214* Other Locations : *AR-AR-Buenos Aires, MX-MX-Mexico City-Mexico City MX Av Insurgente* 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