The Safety Specialist performs day-to-day adverse event reporting and subsequent Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines.
Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information.
Coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities.
Effectively collaborates with various parties such as : project team members, client contacts, investigators, and adverse event / reporters, and third party vendors.
May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.
Minimum Required Education and Experience :
Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 2+ years of clinical experience OR Life Science degree with 2+ years of clinical experience and 1 year of pharmacovigilance experience
Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
Required Knowledge, Skills and Abilities :
General understanding of pathophysiology and the disease process
Detailed knowledge of relevant therapeutic areas as required for processing AEs
Strong critical thinking and problem solving skills
Good oral and written communication skills including paraphrasing skills
Good command of English and ability to translate information into local language where required
Computer literate with the ability to work within multiple databases
Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
Understanding the importance of and compliance with procedural documents and regulations
Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
Strong attention to detail
Ability to maintain a positive and professional demeanor in challenging circumstances
Ability to work effectively within a team to attain a shared goal
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Frequently stationary 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, 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.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
Requires multiple periods of intense concentration.
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.
PPD is an affirmative actionemployer that values diversity as a strength and fosters an environment ofmutual respect. PPD provides equal employment opportunities withoutregard to age, race, color, pregnancy, national origin, religion, sex, gender identity,sexual orientation, disability, veteran status or other status within any otherprotected group.