Case Specialist (Pharmacovigilance) 345 Job at PRODUCTLIFE GROUP, Delaware State

QWZTTEZJRVJDL2VmQ2hjbmNjaDZlSHR2dUE9PQ==
  • PRODUCTLIFE GROUP
  • Delaware State

Job Description

Description de l'annonce:

Description

ProductLife Group is looking for a Case Specialist to join our dynamic team to contribute to the pharmacovigilance activities performed in the Hub:

Responsibilities:

  • Responsible for the Quality control of vigilance cases
  • Medical evaluation of reports
  • Data entry of vigilance cases in ad hoc databases or in other formats agreed with the client
  • Follow-up request of vigilance cases by phone/mail
  • Pre-analysis of complex cases prior to data entry
  • Medical evaluation of files on:
  1. Coding (according to applicable dictionary)
  2. Causal relationship between the effects and the intake of suspect products (according to applicable method)
  3. The expected/listed or unlisted nature of the events/effects/incidents
  4. The seriousness of the events/effects/incidents and the case
  • Identification of submission requirements for each case
  • Validation of certain documents produced by the Data Manager/ Vigilance Associate / documentalist (phone call forms, etc)
  • Closing of vigilance files
  • Identification of requirements and applicable changes to set up ICSR/MLM filters
  • Analysis of inclusion / exclusion of EV/MHRA cases
  • Medical information in support of the medical information division
  • Answering phone calls that generate safety notifications
  • Review of medical information questions and quality complaints in order to identify safety information
  • Key Contact for specific customers (with the support of an Activity Manager or the Line Manager)
  • Writing/setting up quality documents in place:
  1. Related to their activity
  2. Related to particular activities carried out in their Business unit for specific client

Education & Experience:

  • Doctor in pharmacy/ pharmacist by training
  • 1-3 years of experience in a similar position
  • Knowledge of Pharmacovigilance would be an advantage

Profile:

  • Database experience preferred
  • Knowledge of current regulations
  • Process oriented
  • Rigorous and ability to work in a team
  • Use of Microsoft Office tools
  • Ability to multitask
  • Flexibility
  • Excellent communication skills in French and in English for business continuity

Job Tags

Temporary work,

Similar Jobs

Insight Global

Technical Support Specialist Job at Insight Global

 ...A client of Insight Global is looking for a part-time Support Specialist to join their team to support a team of ~25 individuals with...  ...-Thursday from 9am to 4pm . If you are currently a university student, class schedules can be worked around as long as you are able to... 

Five Star Millwork L.L.C.

Logistics Associate/Delivery Driver Job at Five Star Millwork L.L.C.

 ...and the trust our clients place in us. The Role As our Delivery Driver / Logistics Associate, youll keep our projects running smoothly...  ...and commercial job sites Drive and maintain our box truck safely and professionally Verify and organize shipping / receiving... 

Renewal by Andersen Metro & Midwest

Outside Sales Representative Job at Renewal by Andersen Metro & Midwest

 ...Outside Sales Consultant Renewal by Andersen - New Jersey/New York Metro Territory Renewal by Andersen is the custom division of Andersen Windows. Founded in 1903, Andersen Windows has been the worlds largest and most recognized brand for exclusive window and door... 

Towne Park

*SEASONAL* Resort Parking Lot Attendant - Gaylord Texan Resort & Convention Center Job at Towne Park

**_At Towne Park, it's more than a job, you can make an impact._**A career with us is rewarding in more ways than one.As a hospitality...  ...are not eligible for benefits outlined above.**SUMMARY**The Lot Attendant is responsible for accurately collecting and reconciling... 

ConsultNet Technology Services and Solutions

Product Owner - Salesforce Job at ConsultNet Technology Services and Solutions

Salesforce Product Owner/Manager Location: Jacksonville, FL (Hybrid, local candidates only) Department: Enterprise Applications Employment Type: Contract/Contract to Hire *Must be able to work without any sponsorship! Overview The organization is seeking...