Pharmacovigilance Scientist

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

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.

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

#LI-LH1

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

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