41599-pharmacovigilance-medical Review

1 week ago

Bengaluru, India HyreFox Consultants Full time

**Roles and Responsibilities**
- o 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. 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 completeness
- o To participate in audits or inspections.
- o Training and mentoring of new associates.
- o Authoring of process documents
- o Drug safety related activities.

**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

**Other Details**:

- **Keywords**:.

**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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