Position: Report Reviewer Department: Clinical Operations Location: Ahmedabad Key Responsibilities Prepare and finalize the visit report annotation as per protocol and study plans. Ensure finalization of the visit reports as per timeline mentioned in contract, study plans & SOPs. Effectively review trip reports as per annotated report, protocol & SOPs. Ensure the quality of reports are of the highest standards, consistent across sites and visits, errors are minimized and those issues are escalated as appropriate. To follow up on open action items and protocol deviations and coordinate with team for timely resolution of issues. To act as an extension of the CTM/CTM team for the specific purpose of visit report review To observe and escalate safety trends in patients as identified in visit reports Where required, attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends Ensure all necessary trainings, required to improve job performance and knowledge, are completed in a timely manner Any other responsibility assigned by HOD/Project Manager. Qualifications & experience required University Life sciences degree or related field. At least 3 to 5 years of clinical trial-related experience including on-site monitoring experience, CRO working experience is preferred. Adequate knowledge of new product development, including local regulation, GCP, clinical trial operations. Fluent written and verbal communication skills including good command of English language. Ability to handle conflicting priorities. Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output and strong problem-solving skills. Good software and computer skills, including MS Office applications including but not limited to Microsoft Outlook, Word, Excel and PowerPoint.
Position : Auditor Department : Quality Assurance Location : Ahmedabad Key Responsibilities Plan & conduct the Study audits as per audit plan in compliance with internal procedures, protocol and applicable regulatory requirements Plan and conduct Investigator site audit, file/document audit for Clinical Trial Projects to ensure compliance with SOPs, Protocol, ICH GCP, quality system and applicable regulatory requirements. Review study documents like Protocol, Study plans, Informed Consent Document, Case Report Form, Clinical Study Report, Data Management etc. to ensure compliance, correctness and adequacy with ICH GCP and other applicable regulatory requirements Assist in facilitating the sponsor and regulatory audits. Review of final study reports. Plan & conduct system/Internal audits of clinical research processes, procedures, and systems to ensure compliance with applicable regulatory requirements, industry standards, and client expectations. Plan and conduct vendor audit to ensure compliance with study and/or Sponsor requirements and applicable regulatory requirements. Responsible for overviewing the internal QA processes. Qualifications & experience required 3 to 6 Years of experience as a Clinical QA for a CRO. Experience in auditing CT, PK-stats & DM processes & clinical software's like eTMF, CTMS & rSDV.
Position: Medical Safety Executive Department: Patient Safety Location: Ahmedabad Key Responsibilities Prepare and update Aggregate reports/ safety documents such as PADERs, PSURs, DSURs, RMPs, PBRERs, REMS, signal management documents and others, as applicable. Responsible for generation of applicable line listings from safety database, literature screening for inclusion, as applicable. Review and Identification of case reports and AOIs from literature and regulatory sources, as applicable. Independently creates and maintains Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), PMCF Reports and Summary of Safety and Clinical Performance [SSCP] for medical devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance documents and applicable procedures and templates. Creates and maintains PMS documents (PMS plan, PMSR, PSUR) and Risk management file for medical devices and combination products per Guidelines and company SOPs Maintain awareness of changes to regulations /new regulations affecting pharmacovigilance activities, as applicable. Train and mentor new employees/ existing employees in aggregate reports writing and other relevant pharmacovigilance activities, as applicable. Data retrieval from the safety database and EDC system, as applicable. Generate validated ad-hoc reports as well as periodic reports from the safety database, as requested. Provide inputs into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals), as applicable. Review of safety sections of protocol, clinical safety report etc., if required. Consults/ Communicates with multiple internal and external stakeholders (e.g. sponsor/ client/ medical monitor/ pharmacovigilance physician) to decide on an action and/or additional steps to provide complete narratives to the sponsor/client, as applicable. Conduct active follow-up for clarification and missing case details with reporter (e.g. site / clinical study team / HCP / patients / caregiver / literature authors, etc.), if required. Enter initial and follow-up information in the safety database according to the project requirement, if required. Perform coding for all required medical/drug/device term according to given coding dictionaries and applicable coding guidelines, as applicable. Perform/ co-ordinate expedited and periodic reporting according to project-specific requirements, as applicable. Responsible to maintain project-specific folders at shared drive as per the project requirements. Maintain PV related information and all correspondence in relation to Pharmacovigilance activities with agencies and customers based on signed agreements, as applicable. Participate in audits and regulatory inspections in cooperation with QA, as needed. Review and preparation of SOPs, WIs, Guides, training materials, providing inputs to SOPs, as applicable. Request or raise various templets (ADM, UAM, etc.) as per the requirement. Provide various quality and compliance related data/documents or any other data/ documents/ evidences required for the oversight and management of pharmacovigilance activities, as applicable. Other duties assigned by Manager/ COD Management/ Head - PV / Designee. Qualifications & experience required Scientific Degree required. Advanced degree (M. Pharm, PharmD or PhD) desirable. Preferably over 3 to 4 years of experience working in Pharmacovigilance and/or Materiovigilance well versed with medical terminology Experience working with biopharmaceutical companies or Medical Device companies in the EU/ US regions Experience working on multiple product types such as vaccines, cell and gene therapies or medical devices Good understanding of applicable regulations such as ICH, GVP, MDR, US regulations
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