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Pharmacovigilance Safety Scientist

2+ years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: Bachelor’s or Master’s degree in: Pharmacy Nursing Life Sciences Other health-related fields, or equivalent work experience. 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

Job Title:

Pharmacovigilance Safety Scientist

Location: India
Job Type: Full-time
Job Requisition ID: JR 7763
Posted: 24 Days Ago


About ProPharma:

For over 20 years, ProPharma has been improving the health and wellness of patients by providing expert consulting services to pharmaceutical, biotech, and medical device companies. Through its advise-build-operate model, ProPharma offers customizable end-to-end solutions across the full product lifecycle in areas including:

  • Regulatory Sciences

  • Clinical Research

  • Quality & Compliance

  • Pharmacovigilance

  • Medical Information

  • R&D Technology


Job Summary:

The Pharmacovigilance (PV) Safety Scientist supports the Benefit-Risk group in day-to-day operations, ensuring timely and compliant execution of key pharmacovigilance deliverables. The role involves close collaboration with directors, managers, and senior PV scientists to maintain quality standards and deliverables.


Key Responsibilities:

Medical Writing & Aggregate Reports

  • Author aggregate reports such as:

    • PSURs / PBRERs

    • PADERs / Annual Reports / ACOs

    • DSURs

  • Prepare Risk Management Plans (RMPs).

  • Write Signal Management Reports.

Data Handling & Reporting

  • Perform literature searches and validity checks for aggregate reports.

  • Generate and validate line listings from the safety database.

  • Extract and validate data from:

    • RSI (Reference Safety Information)

    • Sales data

    • Previous safety reports

    • Risk Management Plans

    • Signal documentation

Process Management

  • Reconcile relevant process trackers.

  • Provide support for ad-hoc high-priority PV activities.

  • Ensure all deliverables to clients meet regulatory requirements and are submitted on time.

Compliance & Quality

  • Follow ICH-GCP, FDA, EMA, and other global regulatory standards.

  • Identify and author SOPs, work instructions (WIs), deviations, and CAPAs.

  • Contribute to quality discussions and metric compilation internally and with clients.


Required Skills & Abilities:

  • Strong analytical and problem-solving capabilities.

  • High level of attention to detail and quality focus.

  • Excellent organizational and communication skills.

  • Ability to collaborate in a team-based and matrixed environment.

  • Ability to analyze large datasets concisely and accurately for regulatory deadlines.

  • Experience in writing clear, concise, and unambiguous medical text.

  • Proficiency in MS Office and web-based applications.

  • Understanding of global PV regulations and compliance standards.


Education Requirements:

  • Bachelor’s or Master’s degree in:

    • Pharmacy

    • Nursing

    • Life Sciences

    • Other health-related fields, or equivalent work experience.


Experience Requirements:

  • Minimum 2+ years in Pharmacovigilance, with emphasis on:

    • Medical writing

    • Literature search

    • Signal detection

  • Experience contributing to metrics compilation, quality discussions, and report authoring/review.


Diversity & Inclusion Statement:

At ProPharma, we are committed to fostering a diverse, inclusive, and equitable workplace where all employees can be their authentic selves. We celebrate differences and provide a supportive environment that empowers everyone to succeed.


Additional Information:

  • No unsolicited resumes from recruiters or third-party agencies will be accepted.

  • Please refrain from phone calls or emails regarding this job posting.