SAFETY SPECIALIST

Education and Experience:Bachelor’s degree in Life Sciences or NursingMinimum 2-3 years medical/clinical experience or clinical/safety experience and 0 - 2 years SAE processing experienceIn some cases other appropriate education and professional training, for example vocational Health Care Professional qualifications, certified/licensed health care profession and/or relevant research experience may be substituted provided the individual possesses the required knowledge, skills and abilities Knowledge, Skills and Abilities:Competent in the use of Microsoft Word, Excel and PowerPointSafety database skillsGood oral and written communication skillsStrong attention to detailAbility to work within a team or independently as requiredGood knowledge of applicable SOPs, ICH GCP and awareness of pharmacovigilance regulationsAbility to review SAE data for completeness and prepare patient narratives from appropriate documentationCompetent at administrative tasks and project administration activitiesGeneral understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required to process SAEsWorking Conditions and Environment:Work is performed in an office environment with exposure to electrical office equipmentDaily exposure to high pressure and intense concentrationDaily interactions with clients/associatesLong, varied hours on occasionTravel required on occasion domestic and/or internationalPhysical Requirements:Frequently stationary for 6-8 hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wristsFrequent mobility requiredOccasional crouching, stooping, bending and twisting of upper body and neckLight 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-shelfAbility 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 sentencesFrequently interacts with others to obtain or relate information to diverse groupsWorks independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goalsRequires multiple periods of intense concentrationPerforms a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrenceAbility to perform under stress and multi-taskRegular and consistent attendancePharmaceutical 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.

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.