PPD

Senior Drug Safety Specialist

Company
PPD
Location
Bellshill, United Kingdom
Salary
Competitive
Posted
18 Jun 2021
Closes
18 Jul 2021
Ref
1193316
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 Senior Safety Specialist you will be responsible for completing and overseeing daily Pharmacovigilance (PVG) activities.

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: 
Performs and may oversee day-to-day 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. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. 

Essential Functions:  
  • Works independently to perform 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. 
  • Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. 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. 
  • Reviews cases entered for quality, consistency and accuracy, including review of peer reports. 
  • 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 5+ 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: 
Thorough understanding of pathophysiology and the disease process 
Strong knowledge of relevant therapeutic areas as required for processing AEs 
Excellent critical thinking and problem-solving skills with ability to evaluate and escalate appropriately 
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 
Computer literate with the ability to work within multiple databases 
Proficient 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 
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 

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