Responsibilities: * Lead business growth through strategic planning and execution * Manage key accounts and drive revenue expansion * Collaborate with cross-functional teams on product development and marketing initiatives Assistive technologies Travel allowance Health insurance Employee state insurance Gratuity Provident fund
Analyses, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies Responsible for identifying duplicate/invalid ICSRs Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports Perform data entry for all subject information into EDC databases as required Perform peer review, quality review of cases as and when required Perform peer review, quality review of all EDC data entered as required Accountable for sending queries for clarity associated with incoming information if required Ensure accurate and consistent coding of all the events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD). Ensure that case narrative comprises correct and appropriate safety information Ensure that all the cases being processed with quality and submitted in a timely manner without any delays according to the service level agreement. Contributes to safety and pharmacovigilance training programs. Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community. Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services. Training and mentoring of Pharmacovigilance Associates Department: Pharmacovigilance Job Category: ICSR Vacancy: 1 Qualification: B. Pharm.M. Pharm. Experience: 2-3 years Job Code: PZPV012 Job Location: Ahmedabad
Performing Gap analysis of the existing facilities with the required regulatory requirements for API / Excipients / Packaging Material companies / Testing Laboratories. Preparing report and CAPA review in timely manner Preparation of technical documents as per regulatory expectations. Providing Validation / Qualification Services. Imparting training to the employees/site team members To take part in remediation projects allotted by company. Department: GMP Services Job Category: Tech Transfer Vacancy: 1 Qualification: B. Pharm.M. Pharm.M.Sc. Experience: 8-10 years Job Code: PZGMP007 Job Location: Ahmedabad
Responsible to conduct market research (Database) and Prospects making. Responsible for Lead generation (Emails/Calls/Conferences) & Lead nurturing, actively seek out new sales opportunities. Working and managing on CRM, preparing business presentations/documents. Making of feasibility reports, proposals, agreements and payments tracking. Support Marketing efforts like Brand building, running Sales Campaigns Business Account Management Work on CRM To remain up-to-date by acquiring knowledge and skills for improving sales pitch and maximizing sales target achievement. To benchmark sales volume, product mix, and selling price by keeping current with supply and demand, changing trends, economic indicators, and competitors, target based strategic approach Sales Target oriented Job Department: Business Develoopment Job Category: Lead Generation Vacancy: 1 Qualification: B. Pharm.B.Sc.M. Pharm.M.Sc.MBA in Pharma Experience: 3-4 YEARS Job Code: PZBD005 Job Location: Ahmedabad
SOP-QMS preparation and management, Guidance on qualification Review of plant quality documents and critical documents, preparation of Key Documents List Project tracker, Assignment preparation Documents follow up/ status tracking Regular updates, task listing and tracking Plant team training Visit Planning-Agenda, Visit wise discussion with client team Site Visit – feasibility and approval Deputation – whenever required Client wise management of document FAT support / DQ support / Supplier Qualification support Layout review and modifications Department: GMP Services Job Category: GMP Auditor Vacancy: 1 Qualification: B. Pharm.M. Pharm.M.Sc. Experience: 12-18 YEARS Job Code: PZGMP009 Job Location: Ahmedabad
Performing Gap analysis of the existing facilities with the required regulatory requirements for API / Excipients / Packaging Material companies / Testing Laboratories. Preparing report and CAPA review in timely manner Preparation of technical documents as per regulatory expectations. Providing Validation / Qualification Services. Imparting training to the employees/site team members To take part in remediation projects allotted by company. Department: GMP Services Job Category: GMP Auditor Vacancy: 1 Qualification: B. Pharm.M. Pharm.M.Sc. Experience: 6 Years Job Code: PZGMP008 Job Location: Ahmedabad
Performing Gap analysis of the existing facilities with the required regulatory requirements for API / Excipients / Packaging Material companies / Testing Laboratories. Preparing report and CAPA review in timely manner Preparation of technical documents as per regulatory expectations. Providing Validation / Qualification Services. Imparting training to the employees/site team members To take part in remediation projects allotted by company.
Review of the world wide scientific and medical literature in accordance with companies-controlled documents. Maintain organized records of all literature safety reports received and reported. Basic entry of MLM cases received from the authority by uploading and importing XML and RTF files and by analysing received source document. Perform duplicate check. Manage tracking of MLM cases with source of receipt. Ensuring compliance with local regulations and companys global pharmacovigilance requirement. Weekly reconciliation of MLM cases with source of receipt. Deliver training to new joined and team as per requirement. Case processing including data entry, drug coding, MedDRA coding, assessment for expediting of ICSR in accordance with companys standard operating procedure relevant regulations and guidelines. Escalate issues or task outside the normal scope of work etc.
Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities. Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Reconciliation of relevant process trackers. Extraction and validation of data (RSI, Sales, previous reports, RMP, signals). Generation of Line Listings (LL) from safety database Providing reliable support for high priority Ad-hoc activities. Ensure all the reports are drafted within the allocated timelines.
Responsible to conduct market research (Database) and Prospects making. Responsible for Lead generation (Emails/Calls/Conferences) & Lead nurturing, actively seek out new sales opportunities. Working and managing on CRM, preparing business presentations/documents. Making of feasibility reports, proposals, agreements and payments tracking. Support Marketing efforts like Brand building, running Sales Campaigns Business Account Management Work on CRM To remain up-to-date by acquiring knowledge and skills for improving sales pitch and maximizing sales target achievement. To benchmark sales volume, product mix, and selling price by keeping current with supply and demand, changing trends, economic indicators, and competitors, target based strategic approach Sales Target oriented Job
Analyses, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies Responsible for identifying duplicate/invalid ICSRs Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports Perform data entry for all subject information into EDC databases as required Perform peer review, quality review of cases as and when required Perform peer review, quality review of all EDC data entered as required Accountable for sending queries for clarity associated with incoming information if required Ensure accurate and consistent coding of all the events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD). Ensure that case narrative comprises correct and appropriate safety information Ensure that all the cases being processed with quality and submitted in a timely manner without any delays according to the service level agreement. Contributes to safety and pharmacovigilance training programs. Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community. Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services. Training and mentoring of Pharmacovigilance Associates
Performing Gap analysis of the existing facilities with the required regulatory requirements for API / Excipients / Packaging Material companies / Testing Laboratories. Preparing report and CAPA review in timely manner Preparation of technical documents as per regulatory expectations. Providing Validation / Qualification Services. Imparting training to the employees/site team members To take part in remediation projects allotted by company.
SOP-QMS preparation and management, Guidance on qualification Review of plant quality documents and critical documents, preparation of Key Documents List Project tracker, Assignment preparation Documents follow up/ status tracking Regular updates, task listing and tracking Plant team training Visit Planning-Agenda, Visit wise discussion with client team Site Visit feasibility and approval Deputation whenever required Client wise management of document FAT support / DQ support / Supplier Qualification support Layout review and modifications
Pharmacovigilance (PV) Quality Assurance System Governance. Maintaining oversight of the quality systems within Pharmacovigilance department. Review &/or Approval of Quality system documents related to Pharmacovigilance. Ensure compliance with written procedures/policy/manuals. Ensure all time readiness of Pharmacovigilance function for client audits/visits and regulatory inspections. Handling of External Audits, Regulatory Inspections, & client visits related to Pharmacovigilance function. Monitor the deficiencies and deviations within PVD and shall ensure compliance and implementation of Corrective and Preventive Actions (CAPA) in accordance with relevant QMS SOP. On-boarding & training of new joinee within PVD Compliance with defined requirements and completeness of Individual training plans, on-job trainings, Job Responsibilities etc Perform quality review of PV activities to monitor the PV process on regular basis. Conducting or Assisting in QMS Audits, Vendor Qualification Audits, For Cause Audits and Pre-Inspection Audits for PV function of Pharmazone. Addressing external queries pertaining to quality and compliance of PV. Distribution of documents to the PV personnel after coordinating with Quality Management System department. Any other responsibilities assigned by management time to time
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