Job Description

We are looking for Sr. Drug Safety Physicians to do the Medical Review of ICSRs and Aggregate Reports, can do the signal detection & handle medical query/spontaneous ADR cases for a leading MNC CRO

Key Responsibilities

  • Manage daily workload in conjugation with Senior Manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department.
  • Medical Review of ICSR’s in pharmacovigilance database and aggregate reports for the purpose of expedited/periodic submission as per the Regulations and SOPs.
  • Signal detection of the ADRs with cases received from client’s products
  • Medical Review of aggregate reports per the Regulations and SOPs
  • Handling of medical query/spontaneous ADR cases as per applicable SOP
  • Generation and review of SOPs and WIs and execution of company SOPs
  • Monitoring  the  work  progress,  ensure  timely  delivery,  participating  in  status  meetings,  updating project progress to the stakeholders
  • Maintain awareness of changes to/new regulations affecting PVG activities.
  • Execution of company Standard Operating Procedures
  • Trains and mentors new employees in PVG (if required)
  • Builds and maintains good relationships across functional units and company affiliates
  • Complies with applicable ISMS related procedures & policies
  • To carry out necessary administrative duties required for the job.
  • Other duties as assigned by management

 

Key Requirements:

  • M.B.B.S / M.D
  • Relevant experience (3-5 years) in Pharmacovigilance
  • Excellent written & spoken English
  • Good time management and presentation skills
  • Experience in team management

 

We know the industry just as well as you, and are we committed to providing you with the best placement experience possible. 

 

 
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