Drug Safety Physician
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Job Location:
Chandigarh - India
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Overview
Performing medical review of Individual Case Safety Reports (ICSRs); preparation of aggregate reports; performing activities related to signal management for client pharmaceutical products medical review of narratives for Clinical Study Reports (CSRs) according to client guidelines and
Standard Operating Procedures (SOPs) and applicable regulatory requirements
Functional Responsibilities
Responsible for any or all of the following activities including but not limited to:
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 productsensuring 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
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
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Pain Management
- SOAP
- Primary Care Experience
- Medical Management
- Suturing
- Workers' Compensation Law
- Pharmacy Residency
- Botox Experience
- Epic
