28 Icsr Jobs - Page 2

The PV Drug Safety Physician should be able to perform medical review of all types of individual case safety reports (ICSRs) by writing an expert company pharmacovigilance comment. The PV Drug Safety Physician maintains distinctive quality and commitment as the operating philosophy in carrying out all processes., and continually seeks out ways to enhance medical expertise in team both internally and externally. Role & responsibilities Provides medical review of safety events (pre-marketing, post-marketing, device, and drug) and/or other medically related information per assigned tasks and project-specific procedures. Provides input and review relevant safety information for signal detection and risk management activities. Performs safety review of clinical and diagnostic data as part of case processing and aggregate reporting. Provide medical review of aggregate reports (e.g., PSUR, PBRER, DSUR, and ASR). Literature and medical review of the literature search strategy. Serves as the main pharmacovigilance/safety physician point of contact for the customer for the life cycle of assigned projects. Is a member of the signal management committee. Assists with identifying out of scope activities in conjunction with the PV Project lead (as applicable). Attends project team and client meetings (including Investigator meetings) and teleconferences as required. Participates in Business Development activities as requested. Performs other activities as identified and requested by management. Provides input and consultancy to the client in the course of generation of the Company Core Data Sheet/Core Safety Information and Product Information. Provides guidance to Pharmacovigilance and Safety Services staff with regards to the regulatory reporting of adverse events. Assists with generation of project specific procedures (medical review workflow activities). Supports QPPV and management as required. Must regularly liaise with peer medical reviewers and also with vendor medical reviewers in assessing expert outcomes or opinions for all Safety reports. Provides training on medically relevant topics, as and when required. Providing oversight for overall PV and medical science for relevant medical products. Other duties as assigned. Preferred candidate profile MBBS/MD with 2 years of experience in reviewing of ICSR's

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

Position Details: Designation: Assistant Manager Function: Pharmacovigilance Location: Navi Mumbai Role & responsibilities: Supporting in IT computer System validation activities of Safety Database and PV related applications Oversight activities for Pharmacovigilance activities, assess & Implement PV Regulatory Intelligence Managing ICSR Case processing activities, Procedural documents updates Participating in Internal and External Audits & Inspections preparations, mocks and presentation Perform oversight on vendor activities, SLAs and KPIs Knowledge of Aggregate Reports, PV Agreement life cycle management, Reconciliation & Regulatory Intelligence Knowledge of PSMF, Literature screening, Affiliate Management Support other operational activities related to Global Pharmacovigilance as required Contribute towards continuous improvement of PV systems and processes Educational Qualifications: Preferably M-Pharm/ MBBS/BHMS/BAMS Post Graduate Diploma in Clinical Research Pharmacovigilance is preferred Experience: 8 - 12 years of relevant experience Prior ICSR, Vendor Management, safety database experience in Argus or other platform Working knowledge of global EU, US regulations, ICH and GCP Guidelines and MedDRA Must be proficient in MS Office Suite, Computer system validation activities Knowledge and Skills (Functional / Technical) Fluent in Medical terminology. Ability to prioritize and multi-task successfully in a fast paced environment. Ability to interpret and follow regulatory guidelines. Ability to react constructively in a high-energy and fast paced environment. Excellent project management skills with the ability to align internal and external resources.