Are you passionate about improving patient safety through pharmacovigilance? ProPharma, a global leader in regulatory sciences, clinical research, and drug safety, is hiring a Pharmacovigilance Safety Scientist in India. This role is ideal for professionals with experience in aggregate reporting, risk management plans, and signal detection who want to grow their career in a leading life sciences consulting firm.
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Key Responsibilities
As a Pharmacovigilance Safety Scientist at ProPharma, you will:
- Author aggregate reports such as PSURs, PBRERs, PADERs, Annual Reports, ACO, and DSUR.
- Develop and maintain Risk Management Plans (RMPs).
- Prepare Signal Management Reports and conduct literature searches.
- Perform reconciliation of process trackers and validate extracted data.
- Generate and review line listings from safety databases.
- Support high-priority ad-hoc pharmacovigilance activities.
- Ensure deliverables meet ICH-GCP, FDA, EMA, and global PV regulations.
- Contribute to SOPs, deviations, and CAPAs.
- Analyze large volumes of safety data with precision and accuracy.
Qualifications & Skills
- Education: Bachelor’s/Master’s in Pharmacy, Nursing, Life Sciences, or related health field.
- Experience: Minimum 2+ years in pharmacovigilance, with focus on medical writing, literature search, or signal detection.
- Strong knowledge of global PV regulations and safety data analysis.
- Excellent writing, analytical, and organizational skills.
- Proficiency in MS Office and web-based applications.
- Ability to work in a matrix, multicultural environment.
Why Join ProPharma?
- Work with a global leader in pharmacovigilance and regulatory sciences.
- Contribute to improving patient health worldwide.
- Collaborative and inclusive work environment.
- Career growth in PV, medical writing, and drug safety sciences.
Application Process
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