Medical Reviewer @ Mitocon Biopharma

Job Description

Role & responsibilities

Perform single-case medical assessments, including determination of seriousness, expectedness (listedness/labeledness), and causality of adverse events, in compliance with current regulations, SOPs, internal/external guidance documents, Safety Job Aids, and coding conventions.

Determine regulatory reportability of cases received from clinical trials, spontaneous, and solicited sources across assigned therapeutic teams and products, within defined timelines.

Ensure timely submission of expedited safety reports and support achievement of case processing performance timelines for assigned therapeutic areas.

Acquire and maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic teams, as applicable.

Escalate complex or critical safety cases to the Medical Director or appropriate therapeutic team leads when required.
If you meet the above criteria and are interested in exploring this opportunity, please feel free to reach out via DM or share your updated resume.

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Keyskills:   medical reviewer Medical Writing Medical Affairs Pharmacovigilance Medical Summarization