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.

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.

• Works independently to perform first pass review of safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites. Proactively identifies any potential issues and resolves or escalates as appropriate
• Reviews safety data and provides summations for safety review meetings. Reviews designated sections of aggregate reports.
• Independently functions as the Project Lead for medical monitoring services when SAE case processing has not been contracted. Manages project implementation, coordination, maintenance and close out of assigned studies as applicable. Serves as the primary point of contact for clinical project teams on studies and can act as the alliance level lead on larger alliance/multi-protocol studies.
• Creates and maintains medical management plan(s) on studies (as applicable) and ensures that the processes included in the plan document are reflective of the contract and services requested for studies that have department involvement and those that are standalone studies (ex. MM and/or MPC).
• Works independently to monitor the project financial status, unit forecasting, actual realization, and team allocations in systems. Coordinates staff projections based on contract values and actual hours used. Escalates any financial and/or operational risks and can attend risk management meetings to discuss.
• Indpendently determines hours required for out of scope work for the teams and provides this to the finance/study team for contract modifications. Attends meetings to discuss/justify the modification requirements.
• Resolves complex problems through in-depth evaluation of various factors and offers solutions. May assist management in training and mentoring.
• Presents at business development, client, and investigator meetings and participates in strategy/business development calls. Represents studies at risk management meetings.

Education and Experience:

• BS or BA degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN with 5 years clinical experience in an area that provides the individual with clinical expertise of multiple disease processes and autonomy in decision making processes effecting patient care.
• 5+ years clinical safety experience (clinical research monitoring, pharmacovigilance or combination of each)
• Or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities to perform the job.

Knowledge, Skills and Abilities:

• Advanced knowledge of Global GCPs and regulatory requirements for Medical Management and Pharmacovigilance.
• Excellent ability to coordinate multiple complex and global studies.
• The duties of this position involve a high degree of complexity in that multiple issues on multiple projects may have to be handled simultaneously.
• Excellent problem-solving ability.
• Broad based therapeutic knowledge, advanced knowledge of a wide range of diseases and pharmaceutical agents.
• Excellent oral and written communication skills.
• Excellent Attention to detail.
• Ability to work within a team and independently as needed.
• Effective knowledge of Drug Development Knowledge of Adverse Event Trending and Coding.
• Working knowledge of biostatistics, data management and clinical procedures a plus.
• Advanced ability to review safety data; identify trends and provide written documentation of review in the form of a safety report as applicable

• 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.)

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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.