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Pharmacovigilance
Pharmacovigilance

Ensuring safety from development to market

Pharmacovigilance

Pharmacovigilance

Pharmacovigilance

Enovalife is your trusted partner in pharmacovigilance, materiovigilance, cosmetovigilance, and nutrivigilance. Our team of multidisciplinary safety experts (physicians, pharmacists, and PV officers) works closely together in both pre- and post-market phases to provide operational setup and follow-up of safety activities at both global and local levels, with full traceability and regulatory oversight.

Our assets

  • Comprehensive safety case report management (data entry, MedDRA and WhoDrug coding, medical review, narratives, and submission) in various databases (Argus, ArisG, SafetyEasy, etc.)
  • Expertise in clinical studies, literature, and regulatory cases (Eudravigilance, EMA/MLM)
  • Safety report writing, including periodic reports (DSUR, PSUR, PBRER), regulatory submissions (HAS, EMA), and risk management plans
  • Development of the safety section for study protocols, product information, and product overviews
  • Medical literature review with screening (databases, MLM, and scientific journals), assessment, and case processing
  • Signal detection through querying vigilance and regulatory databases, validating signals, and analyzing them
  • Quality control across all safety activities (case quality checks, narrative double-checks, etc.)
  • Audit support from preparation through to execution, including deviation management and CAPA setup
  • Medical information services at levels 1, 2, and 3 through our 24/7 call center, managing relationships with reporters (patients and healthcare practitioners)
Pharmacovigilance

Why choose us?

Platforms & consulting approach

We have been supporting the life sciences industry in managing vigilance activities for many years, with safety scientists and physicians working on clinical trials from Phase I to IV.

Multiclient approach 

Our multiclient approach enables us to anticipate constraints and workload variations throughout a drug’s life cycle. We advise our partners and clients in making strategic decisions and implementing solutions.

Future-proof your safety approach 

As the Orange Group’s CRO, Enovalife is your ideal partner to support you in digitalizing your safety activities.