PPD

Principal Safety Specialist

Company
PPD
Location
United Kingdom
Salary
Competitive
Posted
03 Jun 2021
Closes
03 Jul 2021
Ref
1192117
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
PPD's mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you!  We know that meaningful results not only require the right approach, but also the right people.  We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.  

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 Principal Safety Specialist, you will oversee all aspects of pharmacovigilance services for multifaceted 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 the overall planning, co-ordination and delivery of pharmacovigilance services for large, complex projects. Oversee and may perform day-to-day Pharmacovigilance (PVG) activities 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. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. May directly oversee staff and provide input on individual performance. 

Essential Functions:  
  • Works independently to oversee day-to-day PVG activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. 
  • Functions in a lead role. Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement. Serves as primary point of contact in the absence of the manager. Mentors less experienced staff. 
  • Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states. 
  • Participates in/lead departmental initiatives; Serves as a subject matter expert in designated area. 
  • Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. 


Qualifications:

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:  

  • Excellent understanding of pathophysiology and the disease process 
  • Expertise in relevant therapeutic areas as required for processing AEs 
  • Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately 
  • Solid project management skills with the ability to manage multiple projects simultaneously  
  • Ability to motivate, mentor and provide guidance to less experience staff 
  • Proficient at complex clinical study administration including budget activities and forecasting 
  • Excellent oral and written communication skills including paraphrasing skills 
  • Good command of English and ability to translate information into local language where required 
  • Advanced computer skills with the ability to work within multiple databases 
  • Advanced skills in Microsoft Office products (including Outlook, Word, and Excel) 
  • Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations 
  • 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 


Working Environment:   
PPD values the health and wellbeing 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 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

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