Drug Safety Associate (PharmD)

Job Title: Drug Safety Associate (PharmD)

Location: Mangalore, Karnataka (Onsite)

Experience: 0 - 4 Years

Job Type: Full-time (starts with 6-month Probationary Training)

About the Company:

CoReason.ai is a fast-growing HealthTech company operating at the intersection of Life Sciences and Technology. We are building advanced analytical platforms to help pharmaceutical companies and healthcare organizations make data-driven decisions with precision.

About the Role:

We are seeking a Drug Safety Associate to ensure the integrity and safety compliance of our platform.

This role goes beyond simple data entry. You will apply your clinical knowledge to audit and validate safety data within our digital system, ensuring every report meets the highest standards of patient safety and global compliance (ICH-GCP).

Structure of the Role

• Phase 1 (Month 0-6): You will join as a Trainee Drug Safety Associate on a fixed stipend. You will undergo rigorous training on MedDRA coding, Case Validity, and our proprietary safety platform.
• Phase 2 (Month 7+): Upon successful performance review, you will be converted to a Full-Time Associate with a revised salary package and benefits.

Key Responsibilities

• Case Management & Triage: Perform initial triage and validity assessment of adverse event reports and clinical trial data flowing through our system.
• Medical Coding: Execute accurate medical coding using MedDRA and WHO-DD dictionaries to ensure standardized regulatory data.
• Data Quality Control: Conduct duplicate checks, reconciliation, and quality control (QC) of safety cases to maintain audit-ready data.
• Regulatory Compliance: Ensure all safety activities align strictly with ICH-GCP guidelines, 21 CFR Part 11, and global pharmacovigilance regulations.
• Process Improvement: Work closely with the technology team to provide "Subject Matter Expertise," ensuring that our platform workflows remain clinically accurate and compliant with evolving regulations.

What We Need (Requirements)

• Education: Doctor of Pharmacy (PharmD) is mandatory.
• Core Skills: Strong theoretical knowledge of MedDRA coding, Case Validity Assessment, and Triage processes.
• Regulatory Knowledge: You must be familiar with ICH-GCP guidelines and the basics of Pharmacovigilance (PV).
• Attention to Detail: You will be the final check before data is finalized; precision is non-negotiable.
• Tools: Proficiency in Microsoft Office (Excel, Word).

Nice to Have (Bonus)

• Hands-on training or experience with safety databases such as Argus, ArisG, or LSMV.
• Certification in Clinical Data Management (CDM) or Good Clinical Practice (GCP).
• Experience in authoring or reviewing safety narratives.

Why Join CoReason.ai?

• Innovation: Move beyond traditional manual processing—work in a high-tech, driven environment.
• Career Growth: Gain exposure to the intersection of Life Sciences and Technology—a highly sought-after skill set in the modern pharma landscape.
• Standard 5-day corporate work week.
• Location: Work from our office in Mangalore.

Job Types: Full-time, Contractual / Temporary
Contract length: 6 months

Pay: ₹25,000.00 - ₹40,000.00 per month

Ability to commute/relocate:

• Mangalore, Karnataka: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you currently reside in Mangalore, Udupi, or the immediate surrounding region?

Experience:

• Practice: 1 year (Preferred)

Location:

• Mangalore, Karnataka (Preferred)

Work Location: In person