Pharmacovigilance Scientist

External

Propharmagroup · India

Full-timeRemoteToday

ComplianceDocumentationExcelGCPRisk ManagementSAFe

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About the role

We are seeking a dedicated and detail-oriented Pharmacovigilance (PV) Safety Scientist to join our Benefit-Risk team. In this role, you will support key pharmacovigilance activities, ensuring high-quality delivery of safety and regulatory outputs. You will work closely with senior PV scientists, management, and cross-functional stakeholders to deliver accurate and compliant safety documentation, while maintaining the highest standards of quality and professionalism. Although this is a remote role, candidates based in or near Hyderabad are preferred, with the expectation of attending the office periodically for collaboration.

Responsibilities

Author aggregate safety reports including: PSURs / PBRERs

PADERs / Annual Reports / ACO

DSURs

Prepare and maintain Risk Management Plans (RMPs)

Author and contribute to Signal Management Reports

Conduct literature searches, screening, and validity checks

Perform duplicate checks and literature review using appropriate tools

Extract and validate safety data (e.g., RSI, sales data, prior reports, signals)

Generate and review line listings (LLs) from safety databases

Reconcile and maintain process trackers

Support high-priority and ad hoc pharmacovigilance activities

Ensure all deliverables comply with global regulatory requirements and timelines

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

Contribute to SOP/WI development, deviations, and CAPAs

Skills & Competencies

Strong analytical and problem-solving abilities

Excellent attention to detail with a focus on quality

Effective organizational and time management skills

Ability to work collaboratively in a global, matrix environment

Strong written and verbal communication skills, particularly in medical writing

Ability to interpret and summarize complex scientific data clearly and concisely

Solid understanding of global PV regulations (ICH-GCP, FDA, EMA, etc.)

Proficiency in MS Office (Word, Excel, PowerPoint) and web-based applications

Education Requirements

Bachelor's or Master's degree in: Pharmacy

Nursing

Life Sciences

Or a related healthcare/scientific field

(Equivalent experience may also be considered)

Experience Requirements

Minimum 2+ years of experience in Pharmacovigilance

Experience in one or more of the following: Medical writing (aggregate reports)

Literature search and screening

Signal detection

Experience in authoring and/or reviewing aggregate safety reports

Exposure to quality metrics and client-facing discussions is desirable

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All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Pharmacovigilance Scientist

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