Assist in the ongoing medical scientific review of clinical trial data and generate queries as appropriate to ensure data quality to achieve the following Trend analysis of data quality Identification of common errors and ensuring training to concerned personnel to eradicate said errors Resolution of queries Co&ordination with sources of data collection to correct system errors Contribute to the writing of clinical trial protocols and review of case report forms (CRF) Contribute to the writing and review of clinical study reports, publications and internalexternal presentations Contribute to the writing and review of clinical sections of regulatory documents like Investigators’ Brochures, safety updates, IND NDA submission documents, and responses to Health Authorities questions Participate in project&level scientific and operational discussions, including protocol review meetings, CRF review meetings, investigator meetings, trainings, and scientific advisory boards Work collaboratively with colleagues in other functions including Biostatistics & Data Management, Medical Affairs, Clinical Operations and Medical Writing to meet project deliverables with quality and within timelines Contribute to the development of effective working relationships with investigator sites along with CRAs in assigned projects to optimize scientific quality innovation of clinical trial design, execution, investigator meetings, reporting and publication Train, mentor and coach other departmental staff as required
Eligibility:(UG - BDS, MBBS - Medicine) AND (PG - M.S/M.D)
Salary: INR 4,00,000 - 7,00,000 P.A
Deadline:19th Feb 2025
. Medical training with an MBBS, BDS, BHMS or BAMS degree. At least one year of experience, preferably three years, in a pharmaceutical or CRO environment.. Adequate knowledge of the clinical trial domain across phases and therapeutic areas.. Good communication skills (verbal and written) and ability to work in cross functional teams. Medical writing skills desirable
Piramal Healthcare Limited https://piramalhealthcare.com Piramal Healthcare is one of India’s largest healthcare companies, with a growth track record of above 27% CAGR since 1988. Piramal Healthcare had consolidated revenues of Rs. 2,990 crores in FY2011. With assets across North America, Europe and Asia, Piramal Healthcare is also one of the largest custom manufacturing companies across the world. It has significant presence in the critical care space with sales of anesthesia products to over 100 countries. In FY2011, Piramal Healthcare sold its domestic formulation business to Abbott USA for a consideration of Rs. 17,200 crores and Diagnostic Services business to Super Religare Limited for Rs. 600 crores. The Company has three retained businesses – 1. Pharma Solutions (Custom Manufacturing for innovator companies)2. Piramal Critical Care (Anaesthetic products business) 3. Over the Counter (OTC) Piramal Healthcare Limited is the flagship company of Piramal Enterprises (PEL), one of Indias largest diversified business houses. The group is headed by Mr. Ajay Piramal, who is also the Chairman of Piramal, and among the most respected names in Indian industry. Line of Businesses – Pharma Solutions – The first line of business is Pharma Solutions (Custom Manufacturing) for global innovator pharmaceutical companies. The company’s strategic intent has been to position itself as a partner of choice for global drug companies that want to leverage India’s low manufacturing cost advantage. Company has history of strong relationships with big pharma companies since 1980s based on acquisition of MNC operations in India. Piramal’s approach is to keep the cost competitiveness of its Indian assets at the core, and then build a global outsourcing business around these assets. Such a game plan can offer high end technology and proximity to customers, while also securing them a 30 35% cost reduction. With the acquisition of Avecia and Pfizer’s Morpeth facility in year 2005 06, Piramal has global manufacturing footprint across North America, Europe and Asia. Piramal is today among the global top 10 custom manufacturing companies. Piramal Critical Care Piramal’s Critical Care business is growing presence in the inhalation anesthetic market with global leadership position in halothane and isoflurane through acquisition of Rhodia in year 2005. The recent acquisition of Minrad Inc. and RxElite in US gave Piramal access to Sevoflurane and Desflurane (not yet launched) as well as set Piramal up as one of the important players in the US inhalation anaesthetics market. Piramal is one of the three players globally in this market, and the only one that sells all the currently used gases "Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. OTC The third line of business and the thrust area is the Over the counter business. The product portfolio consisting of leading brands like Saridon, Lacto Calamine, I Pill, Superactiv and Polycrol. Recently launched Superactiv and Itchmosol brands in are now ranked 2nd in their category. Joint Venture Allergan India Private Limited Allergan India is the leader in the Indian ophthalmology space. It plays a pioneering role in developing the ophthalmology marketing the country through its marketing programs and services. Allergan’s major initiatives for the India market include improving awareness, diagnosis and treatment of glaucoma, developing the treatment of ocular surface disease/ dry eye, and introducing new surgical products, particularly in small incision cataract surgery, where it is market leader.