Instagram
youtube
Facebook

Pharmacovigilance Safety Scientist

2+ years
Not Disclosed
10 Aug. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Pharmacovigilance Safety Scientist
Location: India
Job Type: Full Time

About the Company:
ProPharma has been improving patient health and wellness for over 20 years by providing expertise and solutions to biotech, medical device, and pharmaceutical organizations. Through an advise-build-operate model, ProPharma supports clients across the entire product lifecycle with deep expertise in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology.

Job Summary:
The Pharmacovigilance (PV) Safety Scientist will support the Benefit-Risk group by ensuring day-to-day operational activities are executed effectively. The role involves liaising with directors and senior PV scientists, ensuring deliverables meet quality standards, and contributing to regulatory compliance.

Key Responsibilities:

  • Authoring of aggregate reports (PSURs/PBRERs, PADERs, Annual Reports, ACO, DSUR) for submission to Health Authorities.

  • Preparation of Risk Management Plans (RMPs).

  • Development of Signal Management Reports.

  • Performing literature searches and validity checks for aggregate reports.

  • Reconciliation of process trackers and validation of data (RSI, Sales, previous reports, RMP, signals).

  • Generating line listings from safety databases.

  • Supporting high-priority ad-hoc activities.

  • Ensuring compliance with regulatory requirements and timely client deliverables.

  • Authoring and updating SOPs/WIs, and managing deviations/CAPAs when required.

Skills & Competencies:

  • Strong analytical and problem-solving skills.

  • Excellent organizational skills and attention to detail.

  • Ability to work collaboratively in a professional team environment.

  • Understanding of ICH-GCP, FDA, EMA, and other global PV regulations.

  • Ability to analyze large datasets and present scientific conclusions concisely.

  • Strong medical writing skills with ability to summarize and draft unambiguous reports.

  • Proficiency with MS Office and web-based applications.

  • Awareness of global culture and adaptability to a matrix environment.

Educational Qualifications:

  • Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, or a related field.

Experience Requirements:

  • Minimum 2 years’ experience in Pharmacovigilance with a focus on medical writing, literature searches, or signal detection.

  • Experience contributing to quality discussions and compiling metrics.

  • Hands-on experience in literature screening and authoring/reviewing aggregate reports.

Salary Range: ₹6,00,000 – ₹10,00,000 per annum (estimated, based on industry standards for PV Safety Scientists in India).