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Sitanshu Mohan
Senior Executive- Pharmacovigilance
New Delhi
Summary
A healthcare professional with a Master degree in Pharmacy (Clinical Practice) and more than four years of experience in Pharmacovigilance (Identification of ICSR and accumulation of product details from various client provided applications). Accomplished the role with progressive industry background and decisive leadership style. Offers strategic planning abilities, background in change management and forward-thinking mindset. Ready for challenges and focused on meeting future demands.
Overview
5
5
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
Senior Executive
Clinchoice Pvt Ltd
Bangalore
01.2019 - Current
- Checked duplicate search and triage of the received source documents such as for spontaneous cases within agreed timelines
- Performed data entry as well as quality review which includes but not limited to capturing and coding of products (suspect,concomitant and treatment drugs) per product dictionary, coding event (s), medical history, laboratory findings and product indication (s) per MedDRA, performing causality, labeling, seriousness assessments and drafting narratives
- Completed the case processing activities within the stipulated time by prioritizing allocated cases in accordance with service level agreement and regulatory timelines and contribute to the management of daily workflow
- Raised follow up queries, as necessary, with appropriate documentation in the safety database or per applicable procedures
- Completed deliverables and ensure compliance to timelines, quality and training as specified in SLA
- Trained and mentored new project team members
- Product Ingredient Lookup project: Reviewed the product formula details obtained for the sponsor provided consumer products,using consumer systems and tools in order to find the product data points
- Handled client feedback as well as the regular meetings in order the understand and achieve their desired expectation pertaining to the work
- Performed coding of indications, undesirable effects at SOC, PT and LLT levels using MedDRA dictionary and incorporated them in a standard template of the spread sheet
- Identification of the clinical and safety particulars from the source documents (SmPC’s or CCDS’s) as well as MedDRA and WHO drug coding of certain particulars
- Identified Indications, Contraindications, Undesirable effects, Drug Interactions in the provided SmPC/CCDS in order to obtain the MedDRA code for the corresponding fields.
- Streamlined operations to maximize business efficiency and profits.
- Identified opportunities to improve business process flows and productivity.
- Clarified roles, responsibilities and expectations of staff.
Education
Master Of Pharmacy - Clinical Practice
Utkal University
Bhubaneswar, Odisha 09.2016 - 08.2018
Bachelor of Pharmacy -
Indira Gandhi Institute of Pharmaceutical Sciences
Bhubaneswar, Odisha 08.2012 - 06.2016
Skills
Operations oversight
undefinedAccomplishments
- iMED Star Performer 2020
- Clinchoice (formerly known as iMED) Star Performer 2021
Interests
Traveling
Listening to Mythological podcasts
Timeline
Senior Executive
Clinchoice Pvt Ltd
01.2019 - Current
Master Of Pharmacy - Clinical Practice
Utkal University
09.2016 - 08.2018
Bachelor of Pharmacy -
Indira Gandhi Institute of Pharmaceutical Sciences
08.2012 - 06.2016
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