Pharmacovigilance Scientist (Propharma)

Roles and Responsibilities

Key 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