Standard Operating Procedures (SOPs) and applicable regulatory requirementsFunctional 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
* Review of case listings including review of serious unexpected associated listings, listings
of special situations like mortality, paediatric, elderly, pregnancy, lack of effect, etc.
* 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
* Providing support in audits, inspections, and inspection readiness activities, as required
* Mentoring new physicians in the team (as applicable)
* Identifying any areas of concern within the team and raising these with the Project
Manager* Be well versed with safety profile of assigned drugs, labelling documents, client
procedures and international drug safety regulations
* Maintaining current knowledge of applicable global regulatory guidelines
Note: The above statements describe the general nature and level of work to be performed and are not
an exhaustive list of all responsibilities required for the position.Education
A Degree in Medicine (MBBS)
Post-graduation qualification (MD) would be preferredSkills and personal attributes
* Excellent knowledge of medical terminology
* Ability to apply medical judgement, understand, interpret and evaluate data
* Ability to prioritize activities effectively and to meet multiple deadlines successfully with
attention to detail, setting high performance standards for quality
* Fluency in spoken and written English
* Good communication skills
* Attention to detail
* Ability to work in a team
* High level of flexibility and ability to prioritize work
* Awareness of global culture
* Typing and transcription accuracy
* Computer proficiency: an ability to work with web-based applications, and proficiency in
the use of Windows Operating System and the MS Office suite (Word/Excel/ Power Point)
experience
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