Drug Safety Analyst

Job Title: Drug Safety Analyst

Location(s): Pune, India

Job Summary

The Drug Safety Analyst validates AI-generated safety content derived from biomedical literature as well as providing research, analysis and technical support for product development and continual improvement of Pharma Solutions safety products.

The role is ideal for an established PV professional who wants to apply their skills and experience in a different setting, contributing to ongoing product quality and delivery as well as product development in the drug safety space, and continuing to help drive global patient safety.

Role Responsibilities

• Evaluates validates AI-derived or published drug safety content in the regular and evolving production process, applying Scientific Comprehension and Pharmaceutical Industry Knowledge

• Conducts technical and domain research to create product business value, identifying opportunities by linking domain technical facts to broader business perspective through Customer Focus , Pharmaceutical Industry Knowledge and being Data Domain Savvy

• Communicates Effectively and Manages Complexity to clearly articulate product development issues and opportunities in discussions, presentations or documentation, keeping stakeholders focused on the key points.

• Contributes to Collaboration , shows Adaptability and Cultivates Innovation to enable continuous learning and improvement through shared reflection on processes and outcomes

• Drives Results by seeking new ways to optimize efficiency, quality and effectiveness

  Experience, Skills Qualifications

  Essential

• Masters or above in Pharmacy/LifeSciences/Medicine

• 3-5 years experience in PV or related drug safety discipline

• Candidates with significant experience in signal detection and management are preferred

• Strong understanding of PV workflows and fundamental principles of:

  • Case processing, ICSR criteria and application to medical literature, MedDRA coding etc
  • Signal identification and validation, disproportionality analysis, signal prioritization and evaluation, benefit-risk assessment and risk management
  • Aggregate safety reporting
  • Regulatory reporting requirements and compliance needs

• Logical critical thinking, analytic skills, literature review capabilities

• Able to conduct technical domain research, identify issues, trends and opportunities

• Can link technical facts to broader perspectives (business, product, operations) and articulate implications and opportunities

• Strong English-language and scientific expression skills

• Able to conduct data/content checks with good attention to detail

• Self-motivation and enthusiasm with a collaborative attitude

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.