Full job description
Roles and Responsibilitieso Review and verification of appropriate sections of adverse events, appropriate MedDRA coding, labelling, causality and provide a medical assessment comment as needed for ICSR.o Reviews medical content and quality of the Case and ensures that all events from the source documents are accurately coded and verify consistency between source documents and narrative summary.o Actively follow up of adverse events to obtain more information and review of all letters and queries for appropriateness and completeness.
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Start an Ad-hoc follow-up whenever required.o Constantly update domain and operations skills as per the changing Regulatory requirements by reading the updated version of SOP.o Route the Case to Distribution and ensure the case is locked.o Provide feedback for the Case creation and data entry production leads about the quality of data entry in serious cases.o Actively involved in case discussion with client and provide the valuable inputs to the team.o Offline peer review of agreed sample of Cases for assessment of quality of narrative, E2B sender’s comment and medical query completenesso To participate in audits or inspections.o Training and mentoring of new associates.o Authoring of process documentso Drug safety related activities.
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Desired Profile: –
- Adaptable and flexible
- Quick learner and a team player
- Minimum of medical degree (MBBS). Medical degree with higher speciality preferred.
- Min. 2 to 5 years of experience (in ICSR medical review).
- In-depth knowledge of medical terminology
- Good Communication Skills, medical writing skills and Analytical Ability
- Strong English Language proficiency
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- Location Bangalore
- Job Title 41599-Pharmacovigilance-Medical Review (CL 8 & 9)
- Experience 2.0 yrs – 5.0 yrs
- CTC INR 13.00 lacs – 30.00 lacs
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