As a Medical Reviewer in the Pharmacovigilance Department, you will be responsible for managing your daily workload under the guidance of the Manager. This includes individual case processing, conducting literature searches, generating aggregate reports, and completing any other tasks relevant to the department. Your role will involve medical review of Individual Case Safety Reports (ICSRs) in the Pharmacovigilance database, as well as preparing aggregate reports for expedited or periodic submissions in compliance with regulations and Standard Operating Procedures (SOPs). You will be expected to ensure compliance with the Company's SOPs and regulatory requirements, and provide support in signal detection of Adverse Drug Reactions (ADRs) for client products. Additionally, you may be involved in the medical review of Periodic Safety Update Reports (PSUR) and handling medical queries or spontaneous ADR cases as per applicable SOPs. Training and mentoring new medical reviewers in Pharmacovigilance may also be part of your responsibilities. Staying up-to-date with changes in regulations affecting pharmacovigilance activities and communicating these updates to relevant stakeholders is essential. You will be involved in the generation and execution of company SOPs and Work Instructions, and maintaining strong relationships with clients and internal/external contacts. Administrative duties, liaising with international offices and clients, and collaborating with cross-functional teams are also key aspects of this role. Your dedication to maintaining good relationships, following ISMS-related procedures and policies, and performing any other duties assigned by management will contribute to the overall success of the Pharmacovigilance Department. This is a full-time position that requires a Bachelor's degree. Kindly confirm if you hold an MBBS/MD qualification. Please note that the work location is in person, and you should be prepared to work collaboratively with team members to achieve required outcomes and meet timelines.,
Medical Review aggregate reports (PSUR, PBRER, ADCO & DSUR) and screening of scientific literature for periodic submission as per the Regulations and SOPs. Manage daily workload in conjugation with line manager for aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department. Generation and review of SOPs and WIs and execution of company SOPs. Compliance to project guidelines • Execution of Company Standard Operating Procedures Maintain awareness of changes to/new regulations affecting PVG activities. Trains and mentors new medical reviewers in PVG (if required). To carry out necessary administrative duties required for the job. Other duties as assigned by management. Builds and maintains good relationships across functional units and company affiliates. Preferred candidate profile Proficiency in Aggregate Report. Well versed with technical writing requirements for US and EU. Good therapeutic knowledge.
Role & responsibilities Perform operational tasks for all procurement requirements in a specific or group of categories, adhering to category strategy, in line with its financial and operational requirements. RFP management for vendor-based services (open and fair process) and provide time bound execution. Recommend process improvements to reduce timelines. Identify and evaluate potential suppliers and maintain strong vendor relationships to ensure reliable supply and competitive pricing. Participate in managing vendor accounts, responsible for negotiations planning and execution with suppliers on costs, commercial and contractual terms. Track supplier performance to circumvent issues, conduct periodic reviews, resolve any supply chain issues or disputes and achieve higher service levels. Preparation of cost interpretation models based on proposals received from vendors (excel -based template). Identify and propose cost savings opportunities to reduce total spend. Responsible for development of savings solutions and benchmarking of industry standards. Act as a primary point of contact for internal user department procurement queries, projects and data requests. Establishing strong inter-departmental relationship. Proactively manage internal user expectations and use best endeavours to meet reasonable user delivery requirements for projects. Handle day-to-day interactions with stakeholders within organization and vendors. Interface with internal customers and suppliers to ensure best value for the company in line with its strategic, financial and operational requirements along with supply risk reduction. Maintain procurement records, including supplier information, contracts, and pricing history. Support internal and external audits related to procurement activities. Prepare procurement reports and present insights to senior management for decision-making. Drive continuous improvement initiatives to streamline procurement workflows and leverage technology/ tools. Provide with Management Information System Reports, as applicable. Mailbox management and email acknowledgements as per TAT. Preferred candidate profile Masters in supply chain management from well-known institutions and/ or Master’s in logistics, with over 6+ years of relevant experience in service industry Experience in contractual negotiations with vendors along with basic legal knowledge to conclude the contractual agreements. Strong analytical ability to present data clearly and accurately. Strong negotiation and vendor management skills. Working finance acumen. Candidates who have worked in Finance or commercial teams within service organizations would be preferred. Proficient in English – spoken and written both. This position will require good analytical & communication skills along with email writing skills. Strong hands-on experience on MS Office (specifically excel including advanced formulas, Word and PPT). Knowledge/ experience of Power BI would be an added advantage. Open to working in global time zones. Flexibility and time management skills. Proven track record of achieving cost savings and process improvements. Ability to work under pressure and manage multiple priorities.
Role & responsibilities • Provide timely support for medical assessment of initial case triage and also assist in reviewing medical information queries pertaining to ICSRs. • Able to properly rank event based on seriousness criteria, labeling and causality assessment • Causality assessment for all events based on WHO algorithm and ICH guidelines also taking into consideration vendor conventions specific for different therapeutics areas. • Able to give proper labeling assessment for adverse events with reference to different types of product safety. • Use of global safety database (ARISg, ARGUS) in accordance with company SOPs and regulatory requirements and draft a medical expert or pharmacovigilance comment. • Medical review of all codings done by using MedDRA (latest version) with respect to adverse events, indications, laboratory data, medical history or surgical procedures. • Should be able to resolve and also raise any medically significant follow up Query or medical relevant Query for respective ICSRs to designated vendor/client. • Training new associates in pharmacovigilance processes in medical relevant topics like causality/labeling/Medical assessment/Medical review as and when required. • Should also help Vendor in resolving any regulatory medical queries or findings pertaining to ICSR reports • Must be able to review, identify potential signals from ICSRs and provide adequate expertise in management of that signal by intimating the vendor. • Would be an active part of any vendor related AUDITs, safety committee meetings and be responsible for any medical review relevant activities. • Should maintain all medical relevant trackers /Minutes of meetings/training records on a real time basis. • Other duties as assigned by the designated reporting manager Key Competencies: • Proficiency in ICSR. • Well versed with technical writing requirements for US and EU. • Ability to effectively work independently, prioritize, multi-task and meet established deadlines.
Role & responsibilities Provide support for financial analysis and Management Information System (MIS) reports Developing cost center reporting framework. Pricing and costing models for RFPs i.e., Pricing and profitability analysis Creating financial proposals for new requests or change/ modification in original requests for potential or existing clients, along with Pricing and costing estimates for potential and existing clients. Preparation of budgets for client contracts and presentations based on the financial proposal, create excel template-based budgets. Drafting scope of work documents updating financials on contract templates. Monitoring framework for adherence to costs as per assumptions in RFPs. Periodically evaluate the efficacy of finance tools deployed and ensure finance measures remain green Handle day to day interactions with senior stakeholders within organization and planned client interactions/ bid defence meetings/ budget and proposal walkthrough meetings. Manage 2-3 team members and ensure delivery of relevant tasks as per TAT Mailbox management and email acknowledgements (self or via team) as per TAT Preferred candidate profile CA with over 3+ years of relevant experience or CMA with 4+ years of relevant experience or MBA Finance from Tier 2 management schools with over 6+ years of relevant experience Proficient in English spoken and written both. This position will require good analytical & communication skills along with email writing skills. Open to working in global time zones. Strong Finance acumen. Candidates worked in Finance or commercial teams within service organizations would be preferred. Candidate should have good knowledge of direct costs components, revenue components and margin analysis. Strong hands-on experience on MS Office (specifically excel, including advanced formulas, word and PPT). Power BI would be an added advantage.
Role & responsibilities: Responds to inquiries and complaints received from physicians, pharmacies, consumers and sales representatives; investigates / documents the questions & answers on the appropriate forms/database. Supports Medical Information Department in updating and creating standard response letters and FAQs to ensure current and accurate information is being disseminated. Assumes responsibility to collect details of adverse events received by any medium (telephone, fax, email) and perform initial assessment according to local procedures and in accordance with drug safety procedures. Maintains and updates product information and other related documents in APCER or client[1]specific database. Performs thorough medical literature searches in various databases (e.g. OVID, PubMed, EMBASE). Contacts internal resources or clients to solicit information required for high level detail in order to pro-vide accurate answers to product-related inquiries. Supports the creation and review of SOPs and other procedural documents. Prepares and Reviews Weekly/Monthly Reconciliation Reports. Compliance to project guidelines. Execution of Company Standard Operating Procedures. Maintain awareness of changes to/new regulations affecting MI activities. To carry out necessary administrative duties required for the job. Other duties as assigned by management Builds and maintains good relationships across functional units and company affiliates. Note: This is Medical Information Contact Centre role. Preferred candidate profile