APCER is Hiring Drug Safety Physician – MBBS/ MD

APCER is Hiring Drug Safety Physician – MBBS/ MD

24 November, 2022

APCER is Hiring Drug Safety Physician – MBBS/ MD

Job Description:

  • Manage daily workload in conjunction with manager/designee for individual case processing and any other tasks relevant to the pharmacovigilance department
  • Medical review of ICSRs in APCER/Client’s pharmacovigilance database for expedited/periodic submission as per the regulations and SOPs
  • Management of compliance with the organization’s standard operating procedures and regulatory requirements
  • Handling of medical queries/spontaneous ADR cases/performing literature assessment as per applicable SOP (as applicable)
  • Active participation in client calls and discussions on technical issues related to medical review based on the need 
  • Trains and mentors new medical reviewers in PVG (if required) 
  • Complies with applicable ISMS related procedures & policies
  • To carry out necessary administrative duties required for the job 
  • Maintain awareness of changes to/new regulations affecting pharmacovigilance activities 
  • Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes
  • Generation and Execution of company standard operating procedures (SOPs) and work instructions (WI)
  • Liaise effectively and maintain excellent relationship with the clients and internal/external contacts
  • To contact, as required the UK/US office(s),customers/clients and applicable offices in order to achieve required outcomes and meet timelines
  • Builds and maintains good relationships across functional units and company affiliates
  • Other duties as assigned by management                 

Key Competencies:               

  • Self motivated 
  • Good competence with therapeutic and medical terminology 
  • Meticulous attention to detail client focused approach
  • Ability to follow instruction and deliver assigned tasks within agreed timelines 
  • Aptitude to learn new skills and enhance pharmacovigilance knowledge              

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