Drug Safety Specialist - GPV Job at SGS Consulting, Remote

bmRmd0ZFVkdzYjMxZFA1L28rZ05DK0FoVlE9PQ==
  • 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

SysMind Tech

IT - Consultant | Data Security | Data Security - ALL Job at SysMind Tech

Job Title: Consultant | Data SecurityWork Location & Reporting Address: Fort Worth, TXonsite)market rateContract duration: 6 months...  ...Education: Bachelor's degree in Computer Science, Information Technology, or a related field.Experience: 3+ years of experience in information... 

NBC Sports

IT GRC Analyst (Cyber Contract Management) Job at NBC Sports

 ...deliver a wide range of content reflecting our world. NBCUniversal is seeking an experienced Governance, Risk, and Compliance (GRC) Analyst to support various functions within the Security Assurance - Governance team. The ideal candidate will have a strong... 

Rockland Trust

Enterprise Risk Oversight Analyst Job at Rockland Trust

 ...Job Description The Enterprise Risk Oversight Analyst reports directly to the Enterprise Risk Strategist and Reporting Manager and provides analytical and program management support for Risk Appetite reporting and second line of defense oversight of key financial... 

BlueScope Buildings

Staff Accountant Job at BlueScope Buildings

 ...metal coils and toll processing services for industries in the construction and consumer product markets, we pride ourselves on...  ...service, and ongoing innovation to our customers. The Accounting and Finance team maintains key transactional processes for the... 

Challenger Motor Freight

Freight Broker (Operating) Agent Job at Challenger Motor Freight

 ...Challenger is seeking motivated individuals to join our team as Freight Broker (Operating) Agent. As a Freight Broker Agent, you'll play a pivotal...  ...of logistics industry-related sales and operations experience. If you seek more control over your future and income,...