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Pharmacovigilance Due Diligence in Drug Development: A Practical Playbook for Risk Identification, Compliance
Ashraf Youssef1, Tarek A Hammad2
1Medical Safety of Marketed Products, Patient Safety and Pharmacovigilance, Takeda Development Centre Americas, Inc., Cambridge, MA, USA. hgpublications@gmail.com.
Drug Safety
|December 16, 2025
Summary
Pharmacovigilance (PV) experts play a crucial role in pharmaceutical due diligence (DD) by evaluating product safety. This systematic approach helps forecast benefit-risk profiles and identify potential safety barriers for informed decision-making.
Area of Science:
- Pharmaceutical Science
- Regulatory Affairs
- Drug Safety
Background:
- Due diligence (DD) is essential in pharmaceutical in-licensing and acquisitions.
- Safety evaluation is critical for regulatory approval and market access.
- Pharmacovigilance (PV) expertise is vital for assessing product safety during DD.
Purpose of the Study:
- To define the role of PV and safety experts in pharmaceutical DD.
- To outline key safety questions and potential red flags in DD.
- To provide a structured approach for evaluating safety data packages.
Main Methods:
- Focus on safety evaluation within the DD process.
- Identification of critical safety-related questions and potential risks.
- Development of a systematic approach with a playbook and checklist.
Main Results:
- Key safety considerations include organ toxicities, labeling liabilities, and risk management.
- Forecasting benefit-risk profiles and identifying approval barriers is crucial.
- A structured approach aids in proactive and risk-calibrated decision-making.
Conclusions:
- PV experts are integral to assessing the scientific and regulatory viability of pharmaceutical products.
- A systematic safety DD process enhances decision-making in transactions.
- Identifying safety-related barriers proactively mitigates risks and maximizes product value.
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