Senior PV Scientist - Case Processing
About the Role
Company Description
Soterius is a company that works worldwide to help drug makers keep people safe. Soterius offers all the steps you need from watching how a medicine behaves in the body to sorting out safety reports and finding signals that might show problems. Soterius gives summed-up reports answers medical questions and builds safety systems for you. Soterius has workers, in many countries. Soterius mixes science, new tools and careful work to keep your company following rules to make work faster and to protect patients.
Job Summary
The role at Soterius focuses on pharmacovigilance activities. It ensures handling of drug‑safety information. The role may include reviewing safety cases keeping documentation following established procedures and supporting regulatory compliance. The role offers exposure to safety operations and collaboration across functions. The role also involves quality‑focused processes while it helps pharmaceutical clients manage safety information efficiently from start, to finish of the product life cycle.
Key Responsibilities
Perform senior level case processing across intake, triage, submission, data entry. Follow up.
Take responsibility for quality control of processed cases. Keep track of quality standards.
Review MedDRA coding and narrative writing, ensuring a high standard.
Handle complex and escalated cases.
Assist with reports and signal activities when needed.
Help junior PV Scientists and associates.
Make sure GVP compliance and quality are met in all activities.
Help prepare for inspections and audits, for the case processing function.
Experience
Candidates should have at least 2+ years of experience in pharmacovigilance, drug safety, clinical research, scientific functions, or related safety-focused areas.
Key Skills:
Proficiency in end-to-end case processing.
ICSR QC ownership.
Knowledge of MedDRA coding.
Narrative writing.
Familiarity with Safety database knowledge - Argus, LSMV, Veeva or equivalent.
Training and mentoring.
Understanding of GVP and compliance requirements.
Knowledge of consumer health and related product-safety processes.
Career Growth
Pharmacovigilance offers chances to grow in the non clinical field, ICSR processing, quality review, MedDRA coding, safety databases and GVP compliance while learning about drug‑safety work.
With experience pharmacovigilance can lead to Senior Drug Safety Associate, PV Quality Specialist, Team Lead, PV Manager or Pharmacovigilance Operations Lead.
Salary Structure
A Senior PV Scientist - Case Processing with 2 years of experience at Soterius Life Sciences typically ranges from ₹4.5 Lakhs to ₹6.5 Lakhs per year in India.
How to Apply
Visit our job portal and open the relevant Soterius job listing.
Check the role requirements and eligibility criteria.
Upload your updated resume.
Submit your application.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.