Drug Safety Specialist

Position Details

• Experience Required:

   23 years (including internship experience)

• Location:

   Bangalore (Hybrid – 2 days in office: Thursday & Friday)

• Interview Process:

• Round 1: Virtual Interview
• Round 2: Final Face-to-Face Interview

• Notice Period:

   Immediate to 15 days

• Project Duration:

   6 months (extendable based on business needs)

• Work Hours:

   8.5 hours/day (Morning/Afternoon shifts)

• Educational Qualification:

   BPharma/MPharma or other medical-related degrees (including Dental, Drug Safety, etc.)

Key Responsibilities

• Conduct pharmacovigilance activities as per project requirements.
• Collect and track Adverse Events (AEs) and endpoint information.
• Identify AEs, product quality complaints, and other safety data from structured/unstructured sources to assess regulatory relevance.
• Perform duplicate checks in the safety database.
• Enter initial and follow-up case reports into the safety database/tracking system in compliance with SOPs and regulatory guidelines.
• Manage follow-ups and queries effectively.
• Assist in preparing safety reports for regulatory submissions.
• Ensure timely and accurate task completion; provide justifications for any delays.
• Deliver high-quality outputs with appropriate oversight.
• Meet KPIs/KQIs in alignment with company policies.
• Participate in team meetings and training sessions as required.
• Work independently, identify risks, propose solutions, and escalate issues when necessary.
• Perform additional tasks as assigned.

Required Knowledge & Skills

• Strong understanding of the pharmaceutical industry and drug development lifecycle.
• Familiarity with pharmacovigilance principles and regulatory requirements.
• Ability to manage safety data and documentation with precision.