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Provides strategy, medical expertise, review and medical expert signoff of aggregate reports prepared by R&D, OCMS and GMS for regulatory authority submissions, scheduled and ad hoc reviews of safety topics and other documents relevant to the safety of assigned products.

Advises on the appropriate strategy for regulatory authority submissions of safety data in support of license application and provide input into development of safety elements of the submissions and/or Development Plans as required.

Assess proposed safety data accumulation in clinical studies and other relevant studies performed during pre and postauthorisation phases of the product development, and review safety findings from the studies. Assess the presentation of safety data in the study report, Present findings.

Advises and researches implications on health of manufacturing or product quality issues. >

Medical Safety Physician

Designation / Job Role : Clinical Research Associate/Scientist
Job Description :
Assess the benefit/risk of assigned products, working with other Client functional groups within. Ensure strategy and level of surveillance for allocated portfolio of medicinal products is appropriate for the product and any issues surrounding the product. Makes recommendations on actions required to maintain a positive benefit/risk profile of their products and is responsible for strategy for risk minimization if required.

Provides strategy, medical expertise, review and medical expert signoff of aggregate reports prepared by R&D, OCMS and GMS for regulatory authority submissions, scheduled and ad hoc reviews of safety topics and other documents relevant to the safety of assigned products.

Advises on the appropriate strategy for regulatory authority submissions of safety data in support of license application and provide input into development of safety elements of the submissions and/or Development Plans as required.

Assess proposed safety data accumulation in clinical studies and other relevant studies performed during pre and postauthorisation phases of the product development, and review safety findings from the studies. Assess the presentation of safety data in the study report, Present findings.

Advises and researches implications on health of manufacturing or product quality issues.
Speciality : Other
Number of Openings : 1
Hiring For : Not Disclosed
Location(s) : Bengaluru/Bangalore
Country : India
Experience : 4 - 7 year(s)
Salary : Not Specified
Salary Remarks : Not Disclosed by Recruiter
Date Posted : 13-Jan-2015
Application Deadline : Not Specified
Requirements
Education : MBBS- Medicine
M.S/M.D - Any Specialization
Doctorate Not Required
Candidate Profile : MBBS / M.D. Required.
45+ years in pharmaceutical, device and/or cosmetic and personal product medicine, including safety.
A sound knowledge of regulatory requirements for pharmacovigilance globally.
Good communication skills, both written and verbal.
Team member skills.
DecisionMaking And ProblemSolving
Ability to triage safety information and escalate if appropriate to senior management.
Strategy for safety and risk benefit assessment for assigned products.
Recommendations for safety related actions and risk management activities as required.
Represent Office of Consumer Medical Safety on Global Safety Review Group (GSRG), Labelling Working Group (LWG) and present of safety information to senior management.
Review and signatory for safety assessment documents for assigned products.
Interactions with regulatory authorities.
Work planning and assignment within a matrix team.
Company Profile
Posted By : Mr. DocLynk Admin
Organisation Name : Medigrity
Designation : Administration
Job Reference : Not Specified
 
 
   

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