Pharmacovigilance professional with over 7 years of experience including 1.5 years in Aggregate report writing.
Preparing PBRERs, DSURs, Interim PBRERs, Addendum reports, PADERs, PSLLs.
Author and/or contribute to relevant sections of the document within the agreed timelines ensuring consistency with the Core Data Sheet / Investigator鈥檚 Brochure, any Risk Management Plan.
Participate in and lead internal meetings with relevant stake holders from product teams.
Ensure that the document is finalised, approved, signed off, delivered to Regulatory for submission.
Assist in Signal Management activities that includes detecting signals by published literature review and datamine FDA AERS, ...
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