PPD is a leading global contractresearch organization. At PPD we are passionate, deliberate, and drivenby our purpose - to improve health!
Our PV team provides 24 / 7 / 365availability and is fully focused on helping clients identify and applyvaluable insights based on their pharmacovigilance data.
We deploy flexible, scalable technologies andresourcing solutions, along with effective governance and continuous processimprovement to meet the changing needs of our clients.
We aim to create value across all areas ofpharmacovigilance to improve efficiencies and reduce costs.
As a Sr. Safety Specialist you will oversee day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment.
Responsible for case management activities that include coordinating and performing adverse event data entry and coding
Assessing adverse events, case review, follow up with reporter and / or associated HCP
Tracking of reports and regulatory reporting activities
Performs literature surveillance and aggregate reporting
Provides training, mentoring, and work directions to more junior level staff
Participates in candidate interviews
Assists in development and review or procedural documents
Maintains knowledge and understanding of PPD and client-provided SOPs and current FDA regulations
Effectively interfaces with project team members, client contacts and adverse event reporters
PPD offers continued career advancement as a Sr. Safety Specialist, as well as management and specialized opportunities in other departments within PPD.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award-winning training programs speak for themselves.
To learn how PPD can advance your career, apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
Education and Experience :
Bachelor's degree in Nursing, Medical Technology or Pharmacy
2 years of pharmacovigilance experience
2 years of experience working in a healthcare setting (e.g., hospital, clinic, laboratory, pharmacy)
Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
Knowledge, Skills and Abilities :
Excellent written and verbal communications skills
Good Microsoft Word and Excel skills; good understanding of safety database functionality
Strong working knowledge of procedural documents
Strong working knowledge of applicable US regulatory requirements
Ability to identify and set priorities and effectively perform a variety of tasks simultaneously, including those with set deadlines
Strong attention to detail and accuracy with orientation toward careful and meticulous work
Ability to maintain a positive attitude
Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff members
Ability to work effectively within a team to attain a shared goal
Demonstrates initiative on the individual and team level
Ability to maintain focus while working within strict timelines
Strong critical thinking and problem solving skills
Ability to gain clear agreement and commitment from others through persuasion and influence
PPD values thehealth and wellbeing of our employees. We support and encourage individuals tocreate a healthy and balanced environment where they can thrive.
Below is listed the workingenvironment / requirements for this role :
Able to communicate, receive, and understand information and ideas with diverse groups or 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
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities
May require travel (Recruiter will provide more details)