Safety Reporting Specialist

Pharmaceutical Product Development (PPD)

Seoul, Seoul, Korea, Republic of

Job Description

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.       Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.  As a Safety Reporting Specialist, you will be r esponsible for the receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.   Summarized Purpose: Responsible for receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. Assists management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects. Es s ential Functions:  - Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation. - Assists in producing metrics and alerts manager to any quality or timeline issues. - Participates on project teams and may lead projects of small to moderate scope. Provides training and support to other team members. - Performs administrative tasks such as filing and the maintenance of safety reporting systems and information. - Liaises with various departments around safety reporting tasks and the setting up of client accounts. - Participates in audits where required and performs testing activities as needed. - Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives 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 2+ 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:  - Strong knowledge of medical terminology - Good written and verbal communication skills - Good Microsoft Word and Excel skills and solid understanding of safety database functionality - Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines) - Ability to juggle multiple tasks while still delivering high quality results - Strong attention to detail and accuracy with orientation toward careful and meticulous work - Possess the maturity to handle sensitive information and data effectively - Ability to interact effectively with all levels of the organization - Strong critical thinking and problem-solving skills Working Environment:   PPD values the health and well being 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.) PPD Defining Principles:  - We have a strong willto win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD -  If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you


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