6 Signal Management Jobs

As a Technical Designer - Audiovisual (AV) at Avientek, you will be responsible for designing and implementing customized AV solutions. You will work closely with the sales and engineering teams to create exceptional AV systems for clients, ensuring that they meet their unique requirements. Your technical skills will include a comprehensive understanding of AV technologies, such as control systems like Crestron, Extron, and AMX programming and configuration, audio systems including Shure, Sennheiser, and DSP processors like Biamp and QSC, and video systems like LED and LCD video walls, projection systems, and video-over-IP technologies. You will also need expertise in unified communications and collaboration (UCC) integration with platforms such as Microsoft Teams, Zoom, and Cisco Webex, as well as knowledge of signal management using HDBaseT, HDMI, DisplayPort, and IP streaming protocols. Proficiency in design tools like AutoCAD, Visio, and AV design software such as D-Tools for creating detailed schematics and layouts is essential. Additionally, you should have a strong understanding of networking principles, including VLANs, QoS, multicast, and AV-over-IP systems like Dante, NDI, and SDVoE, along with knowledge of AV standards and compliance. In terms of soft skills, you should be able to translate technical concepts into customer-focused solutions, possess strong technical documentation, proposal writing, and presentation skills, and have analytical and troubleshooting abilities with a solution-oriented approach to complex AV challenges. Effective time management is crucial to handle multiple projects and deadlines simultaneously. Ideally, you should have 8+ years of hands-on experience in AV pre-sales engineering with a focus on solution design and technical consultancy, as well as proven expertise in end-to-end AV system architecture and integration for enterprise and commercial projects. Professional certifications such as CTS (Certified Technology Specialist) or CTS-D (Design) and manufacturer certifications like Crestron DMC-E, Extron AV Associate, or Shure Integrated Systems Certification are preferred. A Bachelor's degree in Electronics, Telecommunications, Computer Science, or a related engineering discipline is required. If you are interested in this opportunity, please write to hr@avientek.com.,

The ideal candidate for this position should have 1-2 years of experience in AMS design verification. You will be responsible for developing Verilog/VerilogA/VerilogAMS models for signal and power management modules to support top-level verification. Experience in full chip DV would be an added advantage. You will contribute to the development of the Full-Chip AMS-DV plan and own significant pieces of this verification process. It is essential to have the ability to drive best practices in the field of AMS-DV. In this role, you will work independently to identify bugs and resolve them formally with cross-functional teams. An understanding of analog power IPs will be beneficial as it can help in the debugging of chip-level AMS bugs. Proficiency in using tools such as Cadence Virtuoso, Spectre & Spice simulation, Incisive, and AMS simulators is required. You will utilize RTL and Gates+SDF, including process variation in back-annotated timing simulations. This will involve verifying chip-level timing between analog and digital circuits, parasitic resistance and capacitance, and using Assura parasitic extraction tools. Experience in constrained-random stimulus and auto-checking verification environments, especially constrained-random analog stimulus, is desired. The successful candidate should be able to work efficiently in a fast-paced product development environment. You will manage bug tracking and RTL code coverage, collaborate with design and systems teams to address bugs as they arise, and review digital and analog designs to provide guidance on Design for Verification architecture and features during chip development.,

Job Description Drug Safety Physician At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets. We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk management activities and drive proactive implementation of risk management initiatives to meet global regulatory requirements. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities and can successfully lead and influence external and internal stakeholders. DSP also serves as a subject matter expert for product-specific safety information. Responsibilities: Contributes to the development & maintenance of product safety profile. Involved in all safety surveillance activities, which may include monitoring of adverse event and all other safety information to manage the safety profile of the company products Collaborates with, medical monitors and other functional groups in identification, analysis, and reporting of possible safety-related trends or concerns. Responsible for the evaluation of safety data from pre-clinical studies, clinical studies, literature and other sources to establish safety profile of company products to manage risk to the patients Provides medical input into the identification and utilization of appropriate sources of information and database searches to retrieve relevant data for signal evaluation Discuss results of data evaluation with pharmacovigilance safety review team, drug safety committee and/or other key stakeholders Provides inputs to literature search strategy and review to effectively determine appropriate and relevant literature for the purposes of safety analysis. Responsible for the review of the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) providing expertise to the medical content of the safety specification, risk management plan, risk minimisation measures including the locally implemented risk minimisation measures and drives the implementation of risk minimisation activities in accordance with global regulatory requirements. Provides medical input in ensuring that risk minimisation strategies are implemented appropriately in relevant documents such as product reference safety information Collaborates with external provider representatives in the preparation and review of aggregate reports having thorough oversight over the critical aspects like summary of safety concerns, benefit risk evaluation, conclusion etc Have thorough medical oversight over the external vendors on the medical review of ICSRs Provides medical inputs to deliver accurate safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data Provides medical inputs in responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-functional teams Review and provides medical inputs to the safety sections of CCDS, local label updates, health hazard analysis, QA trend analysis, device hazard lists, CER etc Understands the role of QPPV and contributes to the maintenance of the pharmacovigilance system and process Provides inputs to various pharmacovigilance documents like PSMF, SDEA Provides input and review for key regulatory or clinical documents (i.e. SMP, protocol, IB, SAE/SUSAR, safety sections of DSUR, ASR, CSR, integrated summaries of safety etc.) related to pharmacovigilance Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, signal management, risk management plan preparation and responding to ad-hoc safety questions Participates and supports pharmacovigilance audit/inspection preparation and CAPA management Participates in internal pharmacovigilance committee meetings as well as joint safety meetings with partners. Provides inputs in the preparation/revision of SOPs, working guidance and ensuring pharmacovigilance compliance. Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization. Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc). Trains and mentors the team members. Other Drug Safety Physician responsibilities include: Accountable for maintaining personal readiness in response to internal audit or regulatory inspection Includes knowledge of case processing, expedited reporting and safety database concepts Proactively raises concerns/issues to senior management in a timely and appropriate manner ensures quality and integrity of the issue/event being escalated Demonstrates leadership and interacts collaboratively and effectively in team environment (including safety, clinical development, medical affairs,regulatory, commercial, devices) as well as with external stakeholders Must be an excellent communicator and have strong negotiation skills with an ability to have oversight over CRO activities Strong organisational skills, including capability to prioritise independently with minimal supervision. Qualifications MBBS/PhD/MD with 12+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care setting, or Academia Knowledge of the biopharmaceutical industry, drugs and indications with an understanding of applicable guidelines, regulations and best practices for conduct of pharmacovigilance activities. High degree of professionalism, maturity, business understanding and passion. Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail Ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making. Must have knowledge of common data processing software like MS office tools (Excel, Power Point, Microsoft Word etc) Job Location: Bangalore, India.

We are looking for MBBS - Medical Reviewer with 2-3 years of experience in Pharmacovigilance having expertise in review f aggregate reports. Candidate who are willing to come to office and work from office only can apply. Designation : Asst. Manager Department : Vigilance Competence Center Gurgaon, Qualification : MBBS/MD with 2-3 years of experience in pharmacovigilance with expertise in medical review of aggregate reports (PSURs/PBRERs) (required), with experience in performing medical review of signal management and ICSRs (recommended). Location : Gurgaon (Work from office is must with one-day flexi working option) Job Responsibility Design, develop and maintain procedures for medical review activities (ICSRs, aggregate reports and signal management). Ensure high quality of ICSR, aggregate and signal management deliverables. Perform medical review of ICSRs, aggregate reports (PSURs/PBRERs), Risk Management plans, and signal reports. Participate in/organize review of safety label updates. Mentor and train medical reviewers. Provide product and therapeutic area trainings for the PV team. Provide cross-functional training on pharmacovigilance to medical writing and ICSR team members. Behavioral Competencies Excellent interpersonal communication and writing skills with experience handling cross-functional projects Good conflict resolution skills Ability to work in a multi-cultural/global work environment Good mentoring skill

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate

Role & responsibilities To prepare and review and reporting of aggregate reports (PADERs and PBRERS/PSURs), signal reports, risk management plan reports. To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports. Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role. To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety. To liaise with cross-functional departments such as Regulatory Affairs and Medical Review to ensure seamless coordination of safety-related activities. To establish and maintain effective communication with country-specific pharmacovigilance contacts to support global reporting obligations. Support internal and external audits by providing accurate and timely safety documentation and regulatory compliance records. Interested Candidates please send me resumes to sravana.a@hetero.com