Sushma Humbe
Assistant Manager at Wipro technology
- Role
- Assistant Manager at Wipro
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Sushma Humbe
Drug safety Associate and as medical writer with 10 Years of experience with adequate exposure in project management activity in Pharmacovigilance.Key assignments:Management of case processing activities with extremely high reliability, high quality and in tight timelines according to standard processes and operating procedures. Data Entry of serious and non-serious and Quality check of safety data in pharmacovigilance database (ARISg) for purpose of expedited/ periodic reporting and writing adverse event narratives.Ensuring timely reporting to various regulatory authorities for expedited cases.Review literature articles. Create error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to project management.Management of Compliance with the Company Standard Operating Procedures and regulatory requirements.
Experience
Assistant Manager
Dec 2021 — Present · IN
Education
S.G.R.S. College of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2006 — 2010
Dr.D.Y. Patil Institute Of Pharmacy
Master of pharmacy, Pahrmaceutics
2010 — 2012
Malojiraje Sheti Vidyalay
Hsc
2004 — 2006
Skills
- Formulation
- Pharmacology
- Pharmaceutics
- Scientific Writing
- Technology Transfer
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Affairs
- Pharmaceutical Research
- Clinical Trials
- Regulatory Submissions
- Anda
- Glp
- Drug Delivery
- Research
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