Qualification & Experience Vacancies : 01Qualification : MD / DM (Gastroenterology) Experience : Relevant Experience Location : Raiganj

Qualification & Experience Department : Urology Qualification : MS / MCh (Urology)Experience : Relevant Experience Location : Raiganj

Qualification & Experience Department : Anaesthesia Qualification : MD / DA (Anaesthesia)Experience : Relevant Experience Location : Raiganj

Qualification & Experience                       MBBS  - Fresher / 1-2 years Experience                                          

ResponsibilitiesManage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Data entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA. Determine listedness against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from the reports and ensures its collection and follow-up. Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines. Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines.Qualification & ExpeirenceNon-degree + 2 years of Safety experience * or 4-5 years of relevant experience** Associate degree + 2 years of Safety experience * or 3-4 years of relevant experience** BS/BA + 1-2 years of Safety experience * or 2-3 years of relevant experience** MS/MA + 1-2 years of Safety experience * or 2 years of relevant experience** PharmD + 1-2 years of Safety experience * or 2 years of relevant experience** For PharmD, a one-year residency of fellowship can be considered as relevant experience.

ResponsibilitiesTo involved and support in investigation of failure of any material or product in case of any out of specification (OOS) or OOT or laboratory incident or non-conformity and take corrective and preventive actions. To prepare and check reagents and volumetric solution and standardize it. To raise and implement change control or document change request wherever necessary. To perform chemical analysis to assess the results of testing of Raw Material/Packing material/In-process sample/Validation sample/ finish products and other sample as per standard testing procedure. To follow and ensure Good Laboratory Practices (GLP) and Good Documentation Practices inside Quality Control. To ensure availability the working & impurities standards as per various pharmacopoeias. To assist Supervisor/designee in preparation of SOP and give suggestions to improve system performance. To perform, verify and review the calibration of all the analysis instruments whether performed as per the schedule.

ResponsibilitiesAssist with the overall Safety trackers / applications / tools implementation, support, configuration, and migration related activities. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible for providing all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.Qualification & ExperienceExperience in Safety trackers / applications / tools operations support role. Experience working on any validated document management systems. At least 2 years of experience with drug safety trackers / applications / tools / systems such as intake / SAE / ESR trackers / applications / tools (SharePoint, in house developed). Good working knowledge of Microsoft office tools. Safety System integration knowledge.

ResponsibilitiesDevelop knowledge of safety profiles, labeling, and global regulations Follow established project-specific procedures and workflows Support basic compliance with regulatory reporting timelines Assist with preparation for audits and inspections as directed Learn to review basic metrics Report any issues to supervisors immediately Follow established documentation and archiving procedures Observe client interactions under close supervision Work with team members on basic safety deliverables Participate in internal and client-specific training sessions and complete assigned modules in the Learning Management System (LMS). Ensure timely and accurate completion of Timesheets.Responsible for researching and maintaining drug and device safety reporting related regulatory intelligence. country reviews for assigned countries Accountable for country safety requirement reviews and updates for assigned countries, Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs. Collaborating with and assisting the Global Pharmacovigilance Intelligence Office (GPIO) team in operational day-to-day activities.Qualification & ExperienceMasters in Life Sciences/Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, etc.) or equivalent qualification/work experience

ResponsibilitiesContribute to site activation by: Assisting/ with the site staff access to vendor systems Access reconciliation quarterly Following-up with sites to ensure staff training completion required by the study, including but not limited to vendor systems Coordinating the Investigator’s Site File printing and shipment to sites as per the instructions received from the project team Assisting with the material / equipment shipment to sites Project maintenance Contribute to the project management by providing requested data to the clinical project leadership team (e.g. Principal investigator availability, etc…) Contribute to site maintenance and guarantee inspection readiness by: Managing with quality the Trial Master File (TMF), which includes, but is not limited to: upload documents on time, assist with the update of the Expected Document List (EDL) on and ongoing basis and take the applicable actions to prevent and resolve Quality Issues (QIs). Follow up with site staff members and internal study team members regarding pending documents, needed information or pending actions (e.g. trainings to be completed, data to be added to the Electronic Data Capture (EDC), verification of safety information, etc…) Transfer of documents to sponsor TMF systems (if applicable) Supporting investigator’s payment management Address identified site issues and ask guidance to closure, besides to assist the CRAs with the site management issues closure To assist project teams with trial progress tracking by contributing to ongoing CTMS updates, applicable studies systems and trackers with site information. Apply working knowledge and judgment to identify potential issues and provide feedback to study teams, as needed Follow study timelines to ensure successful outcome of the project Participate in all required applicable trainingsQualification & ExperienceRelevant qualification or equivalent experience required High school diploma or higher – ideally degree in life science or other related background - preferred

ResponsibilitiesFocus on building trustful relationships with TLs and HCPs not covered by field based MSLs, increasing the medical reach and coverage of new specialties /TLs from tier 2 and 3 cities where current field-based MSLs are not reaching out, communicating scientific information about our products and gathering insights to support our decision-making process.  Partnering with internal stakeholders, mainly field based MSL, KAM (Key account manager) and First Line Sales managers (FLSM), the DMSL identifies external customer scientific and educational needs. With an innovation mindset, the DMSL analyzes these insights and proposes content and the channel through which to be delivered, liaising with cross-functional team members (MSL, MA, Clinical operations, BU, amongst others) to create and deliver it.  The DMSL will exchange and disseminate scientific and educational related information with HCPs, engaging with them as a subject matter expert via various innovative TL engagements tactics and formats (both proactive discussions on-label, and reactive discussions for unsolicited off-label questions in alignment with local regulations).  Customer facing will take place via remote channels mainly, with occasional face to face interactions on-need basis.  Responsible for supporting clinical trial team on subjects related to interventional clinical trials. Support with data collection, feasibility & initiation visits.  Responsible for documenting and process medical information queries in alignment with MI handling procedures.  Prepares reports and tracking activities: The DMSL submits timely reports of HCP interactions and events, as well as tracks activities against agreed upon Performance & Development objectives. Qualification & ExperienceBachelor’s degree in medicine, natural sciences, or pharmacology. Advanced degree in science-related field eg. MD, MDS, PharmD, PhD preferred.  2-3 year of experience in the pharmaceutical industry as an MSL preferred or experience in drug information, clinical research and development, or other clinical relevant activities.  Preferably experienced in Cardiovascular and Chronic Kidney Disease in Type 2 Diabetes areas.  Innovation and experimentation mindset and creativity, capitalizing on new technologies.  Digital savviness. Experience in digital content creation preferred. Pragmatic manner, adapting quickly to changing environments.