ICSR & MICC Executive ( Pharmacovigilance )

Please read the JD carefully before applying. 

Proceed only if you are genuinely interested in pursuing a career in Pharmacovigilance (PV) and are comfortable with the requirements of the role.

This is an excellent opportunity to kickstart your career in PV as a fresher. 

Service bond: 2.5 Years

Job Role 01 : ICSR Executive
Eligibility: M pharm/Pharm D/BDS ( female candidates only )
Shift: Day
Salary: 02 LPA
Responsibilities:
o Analyses, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources 

o Responsible for performing end-to-end case processing of Individual case safety reports to meet regulatory timelines 

o Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies 

o Responsible for identifying duplicate/invalid ICSRs 

o Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports 

o Perform data entry for all subject information into EDC databases as required 

o Perform peer review, quality review of cases as and when required 

o Perform peer review, quality review of all EDC data entered as required 

Job Role 02: MICC Executive
Eligibility: M pharm/Pharm D/BDS ( Male candidates only ).
Shift: Night Shift (cab facility)
Salary: 03 LPA
Responsibilities:
o Responsible for receiving phone calls related to adverse events and for book-in of cases received by all source types (phone call/email/fax/mail) into ARIS-g

• o Responsible for following good documentation practices while completing AEM form
• o Responsible for triaging of case
• o Responsible for attaching AEM form or other source documentation to case.
• o Use IRMS to create contacts for callers with inquiries related to AE/PC/MI.
• o Thorough understanding of use of FAQs and product labeling to answer medical information inquiries
• o Thorough understanding of regulatory requirements for safety reporting.
  
  Required skills:
  Excellent English communication skills required.
  Understanding of ICSR,MICC,EDC,ADE,ADR,AEM.