FlasfThink

Safety Database Partner

Dr. Anu Dambalkar
MBBS, Diploma in Pharmacovigilance Senior Drug Safety Physician
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  • Senior Drug Safety Physician with over 7 years of pharmacovigilance and 3 years of clinical experience.  

  • Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs); Periodic Adverse Drug Experience Reports (PADERs); Addendum to Clinical Overview (ACOs); Health Hazard Evaluations (HHEs). Experienced in Case Analysis for Ad Hoc reports and Surveillance Analysis of Non Spontaneous Safety Data for PharmacoVigilance (SNAP)  

  • Experienced in conducting medical review of PBRERs/PSURs, PADERs, HHEs, Ad Hoc Reports, SNAP and Safety Management Team (SMT) Slides which includes checking the case for overall medical cohesiveness, checking the expectedness of adverse events, adding company causality and company comments

  • Trained in Monthly Signal Reports and Drug Abuse Report for FDA

  • Maintaining a knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, aggregate reporting conventions and guidelines, clients’ procedures and international drug safety regulations. Maintaining an awareness of global regulatory reporting obligations.

  • Experienced in conducting medical review of PBRERs/PSURs, which includes checking the case for overall medical cohesiveness, checking the expectedness of adverse events, adding company causality and company comments.

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