Medical Review/ICSR - Senior and Lead positions

☞ Golden Opportunities Pvt Ltd

見る: 103

更新日: 06-05-2024

場所: Coimbatore Tamil Nadu Mumbai Maharashtra Hyderabad / Secunderabad Telangana Pune

カテゴリー: 製薬/化学/バイオテクノロジー 健康/医療 薬剤師/薬剤師

業界: Pharmaceutical & Life Sciences

レベル: Documentation/Medical Writing

ジョブタイプ: Full Time, Permanent

経験: 4 - 8 years

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仕事内容

MBBS qualified with relevant Medical Review/ICSR at Senior and Lead positions


Job Title - Medical Reviewer / Drug Saftey Associate


Candidates Specification Clinical Experience (or) Pharmacovigilance


Educational Qualification MBBS Both MCI & Non MCI


Exp: Relevant experinece 2-3.5 Years into Clinical or PV domain


Job Description

Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR).

Edit the Periodic Report Comment if applicable directly within the Periodic Report Comment field in the Patient Safety database.

Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database:

which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database.

Including the narrative.

Provide product advice as required especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR).

Review the company causality assessment provided by Medical Advisor.

Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project including the narrative, AE/SAE terms, suspect drugs

To provide documentation of the review and case comments in Sapphire in Medical Review workflow.

Maintain knowledge of the marketed drug currently under litigation.

Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff.

Currently: Work from home post pandemic willing to relocate to either Mumbai/Pune/Hyerabad/Coimbatore choice provided

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締切: 20-06-2024

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