APCER is Hiring Drug Safety Physician

APCER is Hiring Drug Safety Physician

9 July, 2022

APCER is Hiring Drug Safety Physician

Role & Responsibilities:

Manage daily workload in conjunction with Manager for individual case processing, literature searches, aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department.

  • Medical review of ICSRs in Pharmacovigilance database and aggregate reports for the purpose of expedited/periodic submission as per the Regulations and SOPs.
  • Management of Compliance with the Company Standard Operating Procedures and regulatory requirements.
  • Support in Signal detection of the ADRs with cases received from client’s products (if applicable).
  • Handling of medical query/spontaneous ADR cases as per applicable SOP (as applicable).
  • Trains and mentors new medical reviewers in PVG (if required)
  • Complies with applicable ISMS related procedures & policies
  • 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) and customers/clients in order to achieve required outcomes and meet timelines.
  • To carry out necessary administrative duties required for the job.
  • Builds and maintains good relationships across functional units and company affiliates.
  • Other duties as assigned by management.

Key Skills:

  • Must have good presentation skills and the ability to give presentations.
  • Strong interpersonal & communication skills
  • Ability to work independently
  • Knowledge of regulatory requirements

Education Qualification & Experience

Education: MBBS / MD

Experience: 1 to 5 Year in Pharmacovigilance

Apply HERE

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