Drug Safety Officer at Cipla

Job Purpose

• Assisting the Drug Safety Manager in ensuring that the Company is at all times, compliant with the relevant laws, regulations and guidelines that govern drug safety and for establishing and maintaining the drug safety system so that information regarding all suspected adverse reactions reported to Company employees, are collected, and collated in order to be accessible to get an overall view.
• In the absence of the Drug Safety Manager, assume the responsibilities of the DSM as the Deputy.

Accountabilities 
Pharmacovigilance (PV):

• Understand various functions of PV and operational aspects.
• Assist with day-to-day PV operational activities.
• Understand ICSRs (Individual Case Safety Reports) management and assessment as per internal procedures.
• Act as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR) and regulatory reporting (RR), in line with company SOPs.
•  Always to ensure the maintenance of a high standard of care quality processing.
• Follow-Up on all AE/ADR related queries received from spontaneous/solicited reports within the timelines specified in company SOPs.
• Update RMP implementation tracking and compile safety sales data on request.
• Highlighting any safety related issues to the attention of the management team.
• Assist in conducting reconciliation of all adverse event reports received by PV from internal (QA/MI and ACC) and external stakeholders.
• Support with the preparation and implementation of PV SOPs.
• Assist in raising and closing out all CAPAs, Deviations and Actions on time as per internal company SOPs.

Accountabilities 

• Understand SDEA obligations in order to ensure all aspects under agreements are dully executed.
• Support the continuous development and improvement of the PV function while upholding Cipla core values
• Understand signal management processes and conduct signal detection activities.
• Serves as Regulatory Intelligence specialist for the PV function.
• Complies with the requirements set out in the PVA/SDEA’s
• Identifies and develops key relationships with Cipla global.
• Leverage compliance expertise and alignment with Global Drug Safety
• Responding and assisting to ad hoc business requests
• Undertaking research on a variety of tasks and project and presenting findings in a confident and professional manner
• Completion of Performance Reviews
• Raising and reviewing of Change Controls for safety variations etc.
• Assist in training of all Cipla employees and distributors/service providers on Pharmacovigilance and act as the learning management system administrator for PV.
• Assist with review and compilation of SDEAs

Education Qualification

• Passed and Completed Tertiary Degree: Degree or Diploma in Health Sciences
• 1-3 years in Pharmacovigilance or Medical Affairs.
• Relevant Work Experience
• 3 years in Pharmacovigilance or Medical Affairs.