Job Description

Support signal detection, evaluation and risk management activities which drive reports related to the continual assessment of benefit- risk for all products. Provide scientific review and interpretation of safety data for the preparation and authoring of aggregate reports including but not limited to Signal Evaluation Reports, PBRER, MSSRs, PSURs, PSUR assessment report responses and PADER.   Maintain distinctive quality and commitment as the operating philosophy in carrying out all processes. Acts as a client contact for aggregate report, signal management, and regulatory intelligence functions. Continually seek out ways to enhance customer service experience both internally and externally. 

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• Contribute to and perform  medical writing/analysis of aggregate safety data and reports (both periodic and ad hoc) 
• Perform aggregate report (PBRER/PSUR/MSSR/PADER) review and generation 
• Work with the submissions team and physicians to create and deliver Periodic Safety Reports to clients 
• Develop and conduct signal detection activities and adverse event trending analysis and prepare signal detection and trending reports 
• Assist in the creation, review and implementation of documents and/or tools to align and improve pharmacovigilance processes 
• Address client questions on report management and processes, as well as complete client notifications as required for report management 
• Other duties as assigned

Qualifications

• Proficient computer knowledge and computer keyboarding skills 
• Proficient with Microsoft Office Suite (Outlook, Word, Excel)  
• Working knowledge of global regulatory authority guidelines for post-marketing drug safety surveillance 
• Excellent writing skills 
• Excellent attention to detail 
• Strong organization and prioritization skills; able to multitask 
• Strong decision making skills 
• Able to work independently and collaboratively in a multidisciplinary team 
• Able to occasionally work extended and/or flexible schedule to meet client requirements 
• Life Science Degree  
• Required: minimum 3 years experience as in Signal Detection or Aggregate Reports
• Preferred: Experience working with safety databases

Additional Information

Candidate must be legally eligible to work in the United States or United Kingdom  

Please note this is a fixed-term position lasting through June 30th, 2022.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.