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Medical Safety Advisor// Mumbai/bangalore/work from home

Keywords / Skills : Safety Analysis, Medical, Mbbs, Safety Officer Activities, Safety Management, MD, PV, Risk Assessment, Functional Safety, Center Of Excellence, Pharmacovigilance, PVP

7 - 12 years
Posted: 2019-05-10


Health Care
Medical Officer
Posted On
10th May 2019
Job Ref code
Job Description
Job Description:

Profile- Medical Safety Advisor(AD)/Global Safety Officer(GSO)

- 7+
Mandatory Skills- Experience in Pharmacovigilance,Aggregate Reports,Signal Detection.
Work Location- Mumbai/Bangalore/Work from home
Minimum 5 years total experience in international PV or equivalent relevant industry experience with relevant clinical experience considered.

Must have experience in to PV and risk assessment expertise; experience in signal management,aggregate safety reports

Job Description :

Provide PV and risk management expertise to internal and external customers
Safety expert for product
Maintain knowledge of product, product environment, and recent literature
Maintain PV expertise, and understanding of international safety regulations and guidelines
Lead cross functional Safety Management Teams (SMTs) and some Global Pharmacovigilance internal team(s)
Communicate with and represent PV position within project/product teams, with external partners,key opinion leaders, and Health Authorities, and during internal and external negotiations.Provide strategic and proactive safety input into development plans
Support due diligence activities and pharmacovigilance agreements

Signal Detection and Assessment -

Responsible for signal detection and analysis
Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
Identify and implement proactive safety analysis strategies to further define the safety profile for both marketed products and products in development
Lead aggregate safety data review activities and coordinate safety surveillance activities
Participate in safety governance process, including presentation of safety analyses

Risk Assessment/Risk Management/ Benefit-Risk Assessment -
Provide proactive risk assessment
Co-lead benefit-risk assessment with other relevant functions
Participate in benefit-risk governance process, including presentation of benefit-risk analyses
Develop risk management strategies and plans and monitor effectiveness
Collaborate with Center of Excellence for Risk Management and Safety Epidemiology

Report Writing -
Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report,Periodic Safety Update Report, Health Hazard Evaluation.
Lead the preparation of Clinical Overview to support labelling changes
Lead the Safety part of the Company Core Safety Information (CCSI) creation and update.Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products.

Skills and Education -
MBBS/MD Degree
Excellent clinical judgment
Capability to synthe and critically analyze data from multiple sources
Ability to communicate complex clinical issues and analysis orally, including formal presentations, and in writing
Able to develop and document sound risk assessment
Demonstrates initiative and capacity to work under pressure
Demonstrates leadership within cross-functional team environment

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