- Preparation of Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports(PSURs), Addendum PSURs, Bridging Reports, PSUR Line Listings, US PADERs] from aggregatedata for pharmaceutical products, in accordance with client conventions and Quality check of aggregatereports- Signal Management- Provide Medical expertise on answering Health Authority Queries in PRAC (Pharmacovigilance RiskAssessment Committee) Assessment Reports- Review of published literature and case listings

• Medical Review of PSURs/PBRERs• Contribute to and provide medical review, analysis and guidance during the case handling andreporting cycle of Adverse Event and Adverse Reaction reports received for investigational andmarketed products• Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overallanalysis of the benefit-risk balance of marketed or investigational products

• Medical Evaluation (ME) of Individual Case Safety Reports (ICSRs), narratives for Clinical StudyReports (CSRs)• SAE Review, signal detection and PADER review• Review of published literature and case listings• Support in the preparation and maintenance of Risk Management Plans• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions