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Pharmacovigilance Scientist

Propharma
Propharma
2+ years
Not Disclosed
India
10 April 24, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Pharmacovigilance Safety Scientist – Benefit-Risk | Remote (India, Preference: Hyderabad)

About ProPharma
ProPharma is a global consulting organization dedicated to advancing patient health and wellness by supporting biotech, pharmaceutical, and medical device companies throughout the product lifecycle. With over 20 years of industry expertise, ProPharma delivers strategic solutions across regulatory sciences, clinical research, pharmacovigilance, quality and compliance, medical information, and R&D technology. Its advise-build-operate model enables partners to reduce risk and accelerate the development and commercialization of innovative therapies.

Job Overview
ProPharma is hiring a Pharmacovigilance (PV) Safety Scientist to join its Benefit-Risk team. This role focuses on delivering high-quality safety and regulatory documentation while ensuring compliance with global pharmacovigilance standards. The position is fully remote; however, candidates based in or near Hyderabad are preferred for occasional in-office collaboration.

Key Responsibilities

  • Author and review aggregate safety reports, including:

    • PSURs / PBRERs

    • PADERs / Annual Reports / ACO

    • DSURs

  • Develop and maintain Risk Management Plans (RMPs)

  • Contribute to signal detection and author Signal Management Reports

  • Conduct literature searches, screening, and validation checks

  • Perform duplicate checks and manage literature review workflows

  • Extract and validate safety data from multiple sources (e.g., RSI, sales data, prior reports)

  • Generate and review line listings (LLs) from safety databases

  • Maintain trackers and support reconciliation activities

  • Assist with high-priority and ad hoc PV deliverables

  • Ensure compliance with global regulatory requirements and timelines

  • Participate in audits and inspections as a Subject Matter Expert (SME), when required

  • Support SOP/WI development, deviations, and CAPA processes

Required Skills and Competencies

  • Strong analytical thinking and problem-solving capabilities

  • High attention to detail and commitment to quality

  • Excellent organizational and time management skills

  • Ability to work effectively in a global, matrixed environment

  • Strong medical writing and communication skills

  • Ability to interpret complex scientific data and present it clearly

  • Working knowledge of global PV regulations (ICH-GCP, FDA, EMA)

  • Proficiency in MS Office tools and web-based applications

Educational Qualifications

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

  • Equivalent relevant experience may be considered

Experience Requirements

  • Minimum: 2+ years of experience in Pharmacovigilance

  • Freshers: Not eligible for this role

  • Preferred experience in:

    • Aggregate safety report writing

    • Literature search and screening

    • Signal detection and risk evaluation

  • Exposure to quality metrics and client interactions is an added advantage

Work Model

  • Remote role across India

  • Hybrid engagement encouraged for candidates near Hyderabad

Diversity and Inclusion
ProPharma is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and collaborative work environment. All applicants are evaluated based on merit, and every candidate receives a response regarding their application status.

Application Process
All applications are reviewed by ProPharma’s recruitment team. The company does not use AI-based screening tools, ensuring a fair and transparent hiring process.

Important Note
ProPharma does not accept unsolicited applications from third-party recruiters. Direct inquiries regarding this role are discouraged.