Drug Safety Specialist - GPV Job at SGS Consulting, Remote

b2lCUUN5MnRYUlJvdkl2M3NZVmVrVUVBL1E9PQ==
  • 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

Work from home,

Similar Jobs

Resource Innovations

Django/Python Developer Job at Resource Innovations

 ...Resource Innovations is seeking and experienced Django/Python Developer to join our growing Customer Engagement engineering team. Our Customer Engagement engineering team develops personalized digital platforms to support the delivery of E-Commerce and retail programs... 

Merck & Co.

Senior Scientist, Custom Automation in Data Rich Experimentation (DRE) - Onsite Job at Merck & Co.

 ...mechatronics, the chosen candidate should have excellent interpersonal, communication, and collaboration skills. The chosen candidate should...  ...in Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely related field A M.S. in Engineering,... 

Compass Group

DISHWASHER (FULL TIME) Job at Compass Group

 ...We are hiring immediately for full time DISHWASHER positions. Location : Texas Health Presbyterian Hospital Plano - 6200 West Parker Road, Plano, TX 75093. Note: online applications accepted only . Schedule : Full time schedule; days and hours may vary.... 

Assurity Transportation Solutions

CDL A Local New Graduate Truck Driver Home Daily Job at Assurity Transportation Solutions

 ...(***) ***-**** The sky's the limit! New Graduate CDL A , home daily with great pay for work, life balance. We value you and your family...  ...1400 weekly Dry Van freight Plus more earning potential Driver Referral Bonus Benefits include, medical insurance, Dental... 

Industrial Plating (Chattanooga)

Precision Machine Operator Job at Industrial Plating (Chattanooga)

 ...Join Our Innovators' Team at Industrial Plating Company Since our inception in 1963, we have been a vanguard in transforming how industries apply protective coatings, continuously partnering with Fortune 1000 companies to ensure cutting-edge industrial performance and...