Drug Safety Specialist - GPV Job at SGS Consulting, Remote

bm8vRjNwNjgrb3JpemNtdk8zeDl4RTA3UlE9PQ==
  • 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

Nulixir Inc.

Office Assistant Job at Nulixir Inc.

 ...paced environment where no two days are the same? Nulixir, a leader in food and beverage innovation, is looking for an exceptional Office Assistant to join our team. This is your chance to be part of a cutting-edge company that's transforming the industry with groundbreaking... 

PTC

SEO Manager Job at PTC

 ...and the work we do possible. PTC is seeking an experienced SEO Manager to lead our evolving Search practice across organic search, AI...  ...entire search landscape. As a strategic member of the Digital Marketing organization, the SEO Manager will be responsible for building... 

Webriy

WordPress Developer Job at Webriy

 ...Description We are looking for a talented WordPress Developer to join Webriy, a leading Web Design company. As a WordPress Developer, you will play a crucial role in creating and maintaining WordPress websites for our clients. Your work will be instrumental in ensuring... 

Domino's Franchise

Part Time Delivery Driver Job at Domino's Franchise

 ...professional company, striving to be number one in carryout, delivery, customer service, sales... everything! While the entire...  ...doorsteps. For this role specifically, we are looking for part-time drivers who mostly work during our busiest hours, around dinner time... 

Private Company

Cabin Crew Aide Job at Private Company

 ...Outstanding communication, discretion, and emotional intelligence. High-level culinary service skills (silver service, guridon, wine knowledge). Crisis management, conflict resolution, and emergency response ability. Fluency in English; additional languages (...