Standard Operating Procedures (SOPs) and applicable regulatory requirements Functional Responsibilities
Responsible for any or all of the following activities, including but not limited to:

• Contributing (authoring and/or medical review) to aggregate reports like Periodic Safety
• Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs),
• Development Safety Update Reports (DSURs), Addendum to Clinical Overview (ACO),Internal Periodic Safety Review (IPSR), Risk Management Plans (RMPs)] or other scheduled or unscheduled reports, as required

• Medical review of ICSRs for marketed and investigational human and veterinary products,ensuring accurate capture of safety data within patient narratives and critical data fields which impact medical evaluation (i.e. seriousness, causality, expectedness assessment, MedDRA coding)
• Providing medical advice to PV Scientists to assist them with processing of ICSRs
• Drafting Analysis of Similar Events (AOSE) summary for Serious Unexpected Suspected Adverse Reactions (SUSARs)
• Signal Management activities including Signal Detection, Validation, Prioritization, Analysis & Assessment
• Review of published literature articles/abstracts
• Medical Review of safety narratives for Clinical Study Reports (CSRs)
• Performing additional drug safety related activities, as assigned
• Interacting with internal or external contacts to resolve issues related to the assigned work
• Identifying any areas of concern within the team and raising these with the Project Manager Education : MBBS/ MD would be preferred 
 Skills and personal attributes
• Excellent knowledge of medical terminology
• Ability to apply medical judgement, understand, interpret and evaluate data
• Fluency in spoken and written English
• Good communication skills
• Attention to detail
• Ability to work in a team
• Awareness of global culture
 

experience

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