Responsibilities Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products. Generates data listings from the safety database and assumes responsibility for accuracy of the data. Complete adverse event follow-up in writing and/or by phone based on requirements for each Client. Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files* Perform safety review of clinical and diagnostic data as part of case processing. Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project. Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER Support Qualified Person for Pharmacovigilance as required. Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues. Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate. Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable) Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings. Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks. Supports interim data analysis for DMC reviews. Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process. Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines. Supports Safety Scientist in signal detection and risk management activities. Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately. Proposes solutions for procedural and technical issues. Supports audits and inspections as required for the assigned projects. Perform other activities as identified and requested by management including but not limited to: Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON.     Qualification & Experience At least 2 years of experience in safety background Hands-on experience in ICSR Must have bachelor's or Master's degree    

Responsibilities Coordinate and contribute to the definition of assigned product area Drive ongoing backlog allocations and prioritization of customer jobs to solve within area of responsibility Define epics and user stories, clearly articulating business requirements for the problems we are aiming to solve - including UX/CX/Support requirements Identify and track metrics and success criteria to create transparency and visibility to program success and opportunities for improvement – Requesting analyses to inform backlog Partner with Product Management leaders to be the voice of product decisions within the organization Represent the customer for assigned product area, demonstrating responsibility for end-to-end customer journey and touchpoints Cross-Functional Coordination and Stakeholder Management Serve as Product Owner for scrum teams covering assigned product area Partner with Product Management leaders to drive portfolio and product strategy Support feature rollouts through alpha, beta and general availability by collaborating with customer-facing teams, analyzing feature impact, and preparing communications Engage with Sales, AM, Product Marketing, and other internal partner teams as needed to determine best ways to communicate product to customers; and to assist Product Management leadership with service descriptions Contribute to the development of overall product management team by lending your knowledge and experience to teach others what you know     Qualification & Experience Bachelor’s Degree or equivalent experience in Product Management 7+ years of product management experience Prior experience with working on healthcare/healthcare interoperability (integrations/HL7/CCDs/Interface Engines) is a plus Experience working with stakeholders in a business environment across cross-functional groups  

Responsibilities ABM will be the responsible for delivering on BCH division HCP strategy by leading the HCP team of 7-8 BOs. ABM will be accountable for increasing Prescription share, Market share and support of Key Opinion Leaders for our brands by effectively Implementing HCP strategy through HCP team. To develop synergies between HCP and Trade team members to achieve organizational goal. To achieving defined sales targets by focused demand generation and collaboration with trade team. To build and maintaining strong & long-lasting relationships with top KOLs and strengthening the brands with them To plan and organize Drs meets, CMEs, Hospital meets with top KOL's in the territory. To facilitate and ensure that team meets all required measurable customer coverage parameters. To analyze data for regional performance, draw interpretations and work on course corrections for better performance delivery. To coach the team members for performance, competencies and potential by reviews, feedback and on the job coaching To identifying new avenues for business development.   Qualification & Experience Science graduate with at least 8-10 years of experience Past experience of HCP management is a must.  

Responsibilities Committed to quality and excellence in compliance and conformance With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned. Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets Contributes independently and manages own time to meet the timelines. Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time. Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system. Makes informed decisions on straight cases within guidelines and policies Support for updates in system for License withdrawals Operate in line with internal SOPs and policies Adhere to standard turnaround timelines Escalate any potential compliance issues to management Support periodic and ad-hoc system reports to estimate metrics Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values Assist in ensuring internal regulatory processes and procedures are well documented Assist in remediation activities Support the teams in ADHOC activities Shares the learning time to time with the team colleagues   Qualificatio & Experience Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. Preferred Year Of Experience - 2 to 4 years of experience Type of Experience – Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferable.  

Responsibilities Carry out case processing activities Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments Review case criteria to determine appropriate workflow for case processing Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately Write and edit case narrative Determine and perform appropriate case follow-up, including generation of follow-up requests Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database Determine reportability of scheduled reports, ensuring adherence to regulatory requirements Consistently apply regulatory requirements and Pfizer policies Participate, as appropriate, in local, internal and external safety activities.     Qualification & Experience Top 10 graduating students of Pharm. D or M. Pharm (Pharmacovigilance/Pharmacology/Pharmacy Practice) or B. Pharm. We prefer students graduating in 2024 over 2023 graduates. But if the graduating students can’t receive their provisional certificates before Jun 2024, we are okay to consider 2023 graduates.  

Responsibilities Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment: Step 1 Assessment for Nitrosamine risk Step 2 Confirmatory testing Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis). Remediation Planning: Effective coordination with the GRL/RRL/CRLs, and extend support as needed towards preparation, review and finalization of Global Regulatory Strategy Documents (GRSDs). Submission Execution: Author required CTD sections for filing of supplements /variations,ensuring effective data presentation and quality, as per the finalized GRSD supporting GRS CMC. Support the data alignment team related to RPS Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. Works under supervision. Performs all assignments using established procedures and general instructions on the process. Remains knowledgeable about current regulations / guidelines and correlates in the assigned projects.     Qualification & Experience Bachelors or Master in Science / Pharmacy Preferred Experience Minimum 3 Years in working independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling post approval changes to health authorities.  

Responsibilities Develop business plans and implement related activities like customer events, sales & marketing campaigns, sales presentations necessary to achieve agreed objectives Accountable for achieving agreed sales, productivity and performance targets within agreed budgets and timescales, provide Key account/hospital network support, market access support, including referral networks. Have a deep understanding in the respective specialist area and priority products. Maintain and enhance knowledge of products, product strategy, positioning, key messages, programs, company developments, customers, and competitors Achieve agreed contact, coverage and frequency targets through various communication channels, ensure customer satisfaction and best in class customer relationship, ensure the accurate and timely completion of all reports, handle enquiries and complaints quickly and professionally and in accordance with company procedures. Contribute positively to the Sales and Marketing team through co-operative relationships and collaborative efforts to achieve team and company objectives. provide input into effective use of promotional funds and territory sales forecasting. Follow all adverse events guidelines, and Code of Conduct Guidelines as promoted by Novartis Demonstrate Behavior in accordance with Novartis code of practices. In case of a Manager/ Leader; the person is responsible for the sales planning; target; reporting; and knowledge of the team/account and of himself/herself. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Distribution of marketing samples (where applicable) Achievement of sales revenue and market share targets vs plan. Responsible for budget allocated to cover customer activities. Customer Satisfaction and Customer relationship building. Maintenance of Key Accounts -Sales Planning and Reporting     Qualifications & Experience 2+Sales experience in Healthcare / Pharma / related business, established Network to target Customer Group desirable Territory knowledge is must. Science educational background is must, B.Sc, B.Pharma Good communication skills Desirable Requirements: Cardiovascular experience

Responsibilities Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department. Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people. Assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and Pfizer expectations. Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate. Support the development of country quality strategic initiatives based on risk and business needs, in close collaboration with key stakeholders. Lead continuous inspection readiness for Quality Assurance. Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues. Ensure appropriate networking and sharing of best practices with Corporate Compliance colleagues and with other compliance functions in other Pfizer affiliates or in the market. Participate in internal Good Manufacturing Practices {also cGMP} audits and support regulatory inspections or corporate audit activities. Perform disposition of clinical trial materials. Communicate with and influence internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations. Ensure appropriate internal networking to develop and maintain close and effective business partner relationship with internal colleagues.     Qualifications & Experience Applicant must have a High School Diploma (or Equivalent) with 10+ years of relevant experience; OR an Associate's degree with eight years of experience; OR a Bachelor’s degree with at least 5+ years of experience; OR a Master’s degree with more than three years of experience; OR a Ph.D. with 0+ years of experience. Pharmaceutical manufacturing/Quality experience Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes Proactive approach and strong critical thinking skills Strong collaboration, relationship management, and interpersonal skills Excellent written and verbal communication Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as PDM, Quality Tracking System Trackwise, Documentum platforms Experience in Quality Systems in pharmaceutical, medical device, or combination product industry Knowledge or exposure to and data science

Qualification & Experience MBBS Experience: 0 - 2 Years   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Committed to quality and excellence in compliance and conformance With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned. Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets Contributes independently and manages own time to meet the timelines. Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time. Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system. Makes informed decisions on straight cases within guidelines and policies Support for updates in system for License withdrawals Operate in line with internal SOPs and policies Adhere to standard turnaround timelines Escalate any potential compliance issues to management Support periodic and ad-hoc system reports to estimate metrics Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values Assist in ensuring internal regulatory processes and procedures are well documented Assist in remediation activities Support the teams in ADHOC activities Shares the learning time to time with the team colleagues   Qualification & Experience Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. 2 to 4 years of experience