DDReg Pharma Pvt. Ltd. is a globally recognized regulatory and pharmacovigilance service provider specializing in compliance, market access, and safety management. The organization supports pharmaceutical companies in meeting global regulatory standards, ensuring product safety, and minimizing risks through robust processes.

With a collaborative and innovative work environment, DDReg offers growth opportunities for professionals in the pharmaceutical and healthcare industry. Our team consists of industry experts, and we aim to deliver high-quality solutions to our clients across various regions.

Job Responsibilities: What Will You Do?

As part of the Pharmacovigilance team, you will play a crucial role in ensuring drug safety and compliance through effective literature handling and ICSR management. Key responsibilities include:

• Literature Screening: Regularly monitor scientific and medical literature for potential adverse event reports.
• ICSR Management: Identify, extract, and submit Individual Case Safety Reports in compliance with regulatory timelines and protocols.
• Report Documentation: Maintain accurate documentation of all case reports screened from literature sources.
• Compliance & Collaboration: Ensure strict adherence to global pharmacovigilance regulations and coordinate with cross-functional teams.
• Regulatory Submissions: Assist in preparing reports for health authorities and stakeholders.

Qualifications Required:

To excel in this role, you must meet the following qualifications:

• Educational Background: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or Pharmacovigilance.
• Experience:
  • 1-2 years or 5-7 years of experience in literature handling and ICSR management in a PV setup.
  • Hands-on exposure to scientific literature screening tools and databases like PubMed, Embase, or similar platforms.
• Regulatory Knowledge: Good understanding of global pharmacovigilance regulations and processes (e.g., EMA, US FDA).

Key Skills for Success:

• Expertise in literature monitoring tools for adverse event detection.
• Strong experience with ICSR submission processes and pharmacovigilance databases.
• Excellent communication and documentation skills.
• Ability to meet strict regulatory timelines and manage multiple tasks effectively.
• Immediate Availability: Only candidates ready to join without delay will be considered.

Location:

• Gurgaon, India
  This role requires on-site work in Gurgaon, ensuring close collaboration with internal teams and stakeholders.

How to Apply:

If you meet the qualifications and are ready to join immediately, please send your updated CV to Sugandha.Mishra@ddreg.in.

• Subject Line: Application for Literature Screening & ICSR Role | Immediate Joiner