The job involves receiving and answering calls from individuals seeking medical services or clarification regarding a Medical Entity, Medical Device, Vaccines, or Cosmetics. You will be required to understand the callers" needs and provide accurate information during both Inbound and Outbound calls. Efficiency is key in this role, as you will need to multitask effectively and demonstrate excellent customer service by furnishing comprehensive information on the products. Additionally, follow-up calls may be necessary in cases where essential information is missing, requiring you to reach out to the reporter or enquirer to gather all the required details. The ideal candidate should have 0-3 years of experience and hold a qualification in B.Pharm, M.Pharm, Pharm D, or BDS. This position is based in Hyderabad.,
As a Lab Technician in the Clinical Pathology Laboratory, you will be required to have 2-5 years of experience in a Medical Laboratory setting. Your primary responsibility will be to work in the Clinical Pathology Laboratory located in Hyderabad. To qualify for this role, you must possess a degree in DMLT or BSC in MLT. If you meet these requirements and are looking to utilize your skills and experience in a dynamic laboratory environment, we encourage you to apply for this position.,
As a Project Lead, your responsibilities will include leading and managing projects, supervising all project-related activities, and facilitating communication between the Project Manager and the team. You will be tasked with recording, maintaining, and tracking metrics for both team members and project performance. Additionally, you will review and evaluate AE case information to determine required actions based on internal policies and procedures. Your role will also involve processing current incoming cases to meet Regulatory timelines, providing guidance for data entry, following up with sites regarding outstanding queries, and addressing reconciliation discrepancies. It is essential to adhere to departmental AE workflow procedures and train and mentor new team members as per project requirements. Moreover, you will be expected to author/draft aggregate reports and quality reviews such as PBRER, PSURs, PADER, Addendum to Clinical Overviews, RMP, and Signal detection reports. The ideal candidate should have 7-10 years of relevant experience and hold a qualification of MBBS/MD/M.Pharm. This position is based in Hyderabad.,
Role Overview: As a Sr. Drug Safety Associate in the Pharmacovigilance Call Center team, you will be responsible for ensuring the safety and well-being of patients by monitoring and managing adverse events related to pharmaceutical products. Key Responsibilities: - Handle incoming calls from healthcare professionals and consumers regarding adverse events or product complaints - Document all relevant information accurately and in compliance with regulatory requirements - Conduct initial assessment of the reported events and escalate them as necessary - Collaborate with cross-functional teams to ensure timely and appropriate follow-up on reported cases - Adhere to standard operating procedures and pharmacovigilance guidelines to maintain high quality and compliance Qualifications Required: - Bachelor's degree in Pharmacy, Life Sciences, Nursing, or related field - 3-5 years of experience in drug safety/pharmacovigilance, preferably in a call center environment - Good understanding of pharmacovigilance regulations and guidelines - Strong communication skills and the ability to handle sensitive information with professionalism,
Role Overview: You should have a qualification of M.Pharm in Pharmacology along with 2-5 years of relevant experience. Your role will involve having preferred CT operational exposure in Biosimilars and small molecules from the Sponsor/CRO platform. Key Responsibilities: - Possess a qualification of M.Pharm in Pharmacology - Have 2-5 years of relevant experience - Demonstrate CT operational exposure in Biosimilars and small molecules from the Sponsor/CRO platform - Preferred candidate would be female Qualifications Required: - M.Pharm in Pharmacology - 2-5 years of relevant experience - CT operational exposure in Biosimilars and small molecules - Female candidate preferred,
As a Regulatory Medical Writer-Clinical trials (RMW-CT), you are responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) as designated by leadership. You will provide support for the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests using available reference materials such as documentation of previous interactions with HAs and sponsors, clinical development documentation, scientific literature, and content provided by sponsor teams. You may be the lead contact for sponsor or designated HAs interactions with cross-functional teams contributing to the preparation of submission materials, including project and timeline management activities. Your role also includes ensuring the accuracy and quality of submission-ready documents using established and effective sponsor and/or internal writing processes. Additionally, you will partner with the sponsor/HAs leadership to prepare high-quality, accurate, and concise documentation supporting the objectives of sponsor/HAs teams and leadership. Key Responsibilities: - Serve as the regulatory lead representative on project teams by partnering with the JSTL outsourcing and operational teams, including functional area contributors, to prepare high-quality, clearly-messaged documents founded in regulation and supported by the science. - Must be highly competent to understand the Clinical Trial Protocol elements including study designs, data analysis, timelines, and patient recruitment. - Coordinate the review, approval, QC, and other appropriate functions involved in the production of regulatory projects. - Independently resolve document content issues and questions arising during the writing process. - Prepare scientific communications for external publication in peer-reviewed journals and presentations at scientific congresses. - Provide leadership and project management expertise for ongoing programs and/or projects and initiatives. - Ensure accurate and timely completion/delivery of information and review of regulatory submissions to the sponsor or its designee. - Communicate regularly with JSTL leadership on timeline/milestone progress for any assigned program. - Assess resource needs as timelines progress and communicate any additional resource requests to the department management team. - Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH, CDSCO, and other governing bodies by following applicable divisional guidelines, templates, and standard operating procedures (SOPs). - Proactively identify and implement tactical process improvements. - Mentor and provide guidance and oversight to support staff, including other participating writers and/or external vendor resources and agencies. Qualification Requirements: - A minimum of a Bachelor of Science in life sciences with significant relevant writing experience. - A relevant advanced degree (e.g. MS Pharmacy, PharmD, PhD, MD) is preferred, and higher education may compensate for years of experience. - A certificate in regulatory affairs and/or medical writing is highly preferred. - Minimum of 2-4 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia required, or in a related area such as quality, regulatory, clinical research (Phase I-IV), or product support/R&D. - Good understanding of clinical development processes including principles of clinical study operations, ICH-GCP guidelines, and IJME guidelines. - High-level content writing experience and experience with clinical development regulatory documents required, with working knowledge of statistical concepts and techniques. - Excellent written and oral communication skills. - Expert in assimilation and interpretation of scientific content with adeptness in the ability to translate for the appropriate audience. - Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy. - Peer-review and editing skills are a plus. - Knowledge and expertise with Common Technical Document (CTD) content templates, electronic document management systems, and information technology. - Excellent working knowledge of software programs in the Windows environment including MS Word/PowerPoint/Excel, and Adobe Illustrator.,
As a Lab Technician at Clinical Pathology Laboratory, you will be responsible for conducting various medical laboratory tests. Your role will involve handling samples, performing tests, and ensuring accurate results. Key Responsibilities: - Conducting medical laboratory tests as per the standard operating procedures - Handling and processing samples with care to avoid contamination - Maintaining laboratory equipment and ensuring their proper functioning - Recording and documenting test results accurately - Adhering to quality control and quality assurance measures in the laboratory Qualifications Required: - Diploma in Medical Laboratory Technology (DMLT) or Bachelor of Science in Medical Laboratory Technology (BSc MLT) - 2-5 years of experience in a medical laboratory setting Please note that this position is based in Hyderabad and falls under the Clinical Pathology Laboratory department.,