06 Aug
|
Fact Personnel
|
Mumbai
06 Aug
Fact Personnel
Mumbai
Mandatory Qualification required : MBBS from India
Profile: Medical reviewer
Experience: 01 to 2 year of medical review of PSUR/PBRER/RMP/ACO document
Roles & Responsibilities:
- Medical review of PSUR/PBRER/ACO / RMP (Aggregate reports).
- Management of queries from regulatory agency/authority
- Resolving of aggregate team queries regarding aggregate reports.
- Assist in SOP and SGD of Aggregate reports updating as per requirement
- Assist in any deviation/CAPA filling
- Facing the Audit/Inspections
Technical skills required: Microsoft office, word, power point.
Valuable communication skill written and verbal
Good knowledge of Regulatory guidelines like EMA, MHRA, South Africa, Kazak, Ukraine etc.
Clinical experience and ICSR medical review experience - 06 month- 01 year
📌 Medical Reviewer (Mumbai)
🏢 Fact Personnel
📍 Mumbai