Job Title: Clinical Subject Matter Expert (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 Clinical Subject Matter Expert (PharmD) to serve as the critical bridge between clinical science and software engineering. This is not a traditional data-entry or routine Pharmacovigilance role.
Instead, you will actively guide the development of our advanced AI platforms and applications for pharma industry. By providing vital medical context to our tech teams, you will ensure our software is clinically accurate, compliant, and built to solve real-world pharmaceutical challenges.
Structure of the Role
- Phase 1 (Month 0-6): You will join as a Trainee SME on a fixed stipend. You will undergo rigorous training on our proprietary platform, clinical data structures, and how clinical logic translates into software development.
- 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.
- Clinical Trial Data Workflows: Guide how our software handles clinical trial data, ensuring the platform accurately interprets study protocols, adverse events, and complex safety narratives.
- Output Validation & Quality Control: Audit and validate the outputs generated by our software (e.g., automated medical coding using MedDRA/WHO-DD or AI-generated case summaries), ensuring the system performs with the highest clinical precision.
- 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 Clinical Knowledge: Strong theoretical understanding of Clinical Trials, Triage processes, Case Validity, and medical coding (MedDRA, WHO-DD).
- 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: ₹20,000.00 - ₹25,000.00 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
