Drug Safety Specialist - GPV Job at SGS Consulting, Remote

dm16TXZ6Mk85aW5BeVVPZGo5V3RFQ0FBdnc9PQ==
  • SGS Consulting
  • Remote

Job Description

Job Responsibilities:

  • Communicates with internal and external parties on case content and replies to case-related queries.
  • Makes decisions on case processing matters for prioritization, FU significance, seriousness, listedness, coding queries, etc.
  • Initiates case corrections, as needed.
  • Approves case corrections, as needed
  • Supports late case investigations by PV COPE team
  • Performs clinical open query investigations
  • Provides support for the creation/update of training materials in collaboration with the Data Assurance Manager and PV Training team.
  • Assists in facilitating finalized training sessions (PV processes and systems) for vendors and relevant case processing staff in collaboration with the Data Assurance Manager and PV Training team.
  • Provides support to global Data Assurance teams and other internal departments, as appropriate

Skills:

  • 5+ years relevant experience within Pharmacovigilance
  • Knowledge and understanding of PV regulatory requirements and ICSR processing procedures globally and in America’s region
  • Has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.
  • Present solutions to problems that require the regular use of creativity and ingenuity, while safeguarding Client’s compliance.
  • Ensures case processing and case quality are maintained at highest standards at all times
  • Strong interpersonal skills and multi-cultural /intercultural awareness; able to develop effective relationships through collaboration.
  • Good communication skills in English (written and spoken)
  • Ability to work independently in seeking materials needed for completing daily tasks.
  • Ability to work in a fast-paced environment.
  • Working knowledge of ARGUS safety database
  • Experience with Word, Excel, PowerPoint, Microsoft Teams and SharePoint sites
  • Experience with working from home

Education/Experience:

  • BS/MS degree in life sciences or equivalent (RN preferred)

Job Tags

Remote job, Work from home,

Similar Jobs

Multipurpose Arena Fort Worth

Parking Lot Attendant (Part-Time) Job at Multipurpose Arena Fort Worth

Parking Lot Attendant (Part-Time)Trail Drive Management Corporation Dickies Arena of Fort Worth, TX Dickies Arena is a 14,000 seat, spectacular multipurpose venue located adjacent to the Will Rogers Memorial Center campus in Fort Worth, Texas. The arena is owned... 

Alter Domus

Sales Development Officer Job at Alter Domus

 ...careers.alterdomus.com Your role Work with the global Sales team to aid and analytics for potential New Logo targets. Be...  ...across our offices~24/7 support available from our Employee Assistance Program~ The opportunity to invest in our growth and success... 

Your Bright future

Healthcare & Wellbeing Consultant | Remote Miami Job at Your Bright future

 ...supports both your wellbeing and professional growth? Were seeking motivated individuals who want to take their experience in healthcare, people leadership, or wellness and apply it within a supportive, education-focused environment. This opportunity offers the flexibility... 

Electra Link Inc

Low Voltage Cable Technician Job at Electra Link Inc

 ...Electra Link is seeking a Low Voltage Cable Technician to become an integral part of our team! You will help with the installation, of various types of cabling. MUST be comfortable working from a lift/ladders. Job Responsibilities: Pulling, test, and terminate various... 

People Conquest

Maritime Security Guards (Cruise Ships) Job at People Conquest

NOW HIRING Maritime Security Guards (Cruise Ships)Immediate Embarkation | International Waters By PEOPLECONQUEST HR Recruitment Experts We are recruiting Maritime Security Guards for leading cruise lines. Responsibilities: Enforce and monitor the Ship Security...