Dharmender Rathee
Associate Director at Astrazeneca
Based in Mississauga, Canada
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Seniority
Director
Department
Manufacturing & Production
Location
Mississauga
Industry
Pharmaceutical Manufacturing
Company size
78K
Contact information
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d•••••••@astrazeneca.com
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Background
About Dharmender Rathee
Skilled professional with over 12 years of safety/pharmacovigilance and regulatory medical writing experience. Expert with a demonstrated history of managing projects in various domains of Safety/Pharmacovigilance, and Regulatory Medical Writing. Main areas of expertise include Regulatory medical writing [(Clinical Study Reports (CSRs), Investigator’s Brochure (IB), Clinical Study Protocol, and CSR narratives)], Aggregate reports [(Periodic Benefit-Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experiences Reports (PADERs), Bridging Reports, Addendum to Clinical Overviews (ACOs), ad-hoc reports/Drug Safety Reports (DSRs), Response to health authorities queries and Risk Management Plans (RMPs)] and Signal Detection and Risk Management. Well versed with clinical (RAVE, Inform, PPD global and I medidata) and global safety databases (ARGUS and ARIS-g).
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