Aggregate Report Writer - Pharma Covigilance - Pharma/CRO

Looking for Aggregate Report Writers

- 8 -15 years of Pharma co-vigilance experience (including years of authoring and review of periodic safety reports) in Pharmaceutical Company or Contract Research Organization (CRO).

- Knowledge of drug safety & clinical development and ICH/GCP principles, GVP modules, global pharma co-vigilance regulatory requirements across ICH regions

- Experience in diverse therapeutic areas will be preferable.

- Project management activities (Compiling to Publishing Aggregate reporting activities)

- Good knowledge of pharma co-vigilance practices, particularly in relation to periodic safety reports.

- Project management activities (Compilation to Publishing activities)

- Good knowledge of global Pharma co-vigilance regulatory requirements.

- Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions.

- Ability to evaluate, interpret and synthesize scientific data (analytical thinking).