Drug Safety Specialist - GPV Job at SGS Consulting, Remote

RU9KQjJER05YbGQ0c2NBNWZJaEc3SGlFV1E9PQ==
  • 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

Myatt Landscaping & Construction

Landscape Designer Job at Myatt Landscaping & Construction

 ...We are looking for an experienced landscape designer to join our team. The person selected should have experience designing projects for both residential and commercial clients, involving a wide range of elements. Our main consideration when reviewing portfolios will... 

Lensa

Associate Creative Producer, Sports, Podcasts Job at Lensa

 ...college football content, who will play a key role in bringing digital programming to life. If you have a deep passion for sports, social media, and are an expert video and graphics editor, this is the perfect job for you. The ideal candidate has a versatile production... 

Kaplan, DiTrapani, Faria & Manin LLP

Will Trusts & Estates Attorney Job at Kaplan, DiTrapani, Faria & Manin LLP

 ...Established Real Estate Law firm in Syosset, NY, seeks Attorney to expand our Wills, Trusts, and Estate Practice. Tremendous upside opportunity and Partner...  ...Attorney, you will: Counsel clients on estate planning strategies, including wills, trusts, and powers of attorney... 

City and County of San Francisco

Police Officer - New Recruit (Entry Level) Job at City and County of San Francisco

Police Officer - New Recruit (Entry-Level) Department: San Francisco Police Department (Q002) | Location: San Francisco, CA | Status: Full-time, Permanent Civil Service Quick Facts Salary Range: $115,778 - $147,472 Exam Type: Continuous | List Type: Entrance | Rule: Rule...

Ross Learning Academy Childcare Center, LLC.

Private PreK Lead Teacher Job at Ross Learning Academy Childcare Center, LLC.

Summary We are seeking an enthusiastic preschool teacher to guide a classroom of young children in a variety of educational activities, including arts and crafts, free play, storytelling, and class outings. Your prime responsibility is to teach them the fundamental...