In Pursuit of Better Health Solution.

Perform authorization, Qualification, Validation and Re-validation activities on instrumentation, Utilities, and Facility utilized in the Pharmaceutical Drug producing and Quality Testing in office approved CGMP facilities. Draft and review Validation Life Cycle documentation for instrumentation, Utilities and Facility like Qualification protocols [Installation Qualification (IQ)/ Operational Qualification (OQ)/ Performance Qualifications (PQ)], Specification documents like User demand Specifications (URS), practical demand Specifications (FRS), software system Specifications (SS); Validation outline reports, Deviations reports, Periodic Reviews. Author Traceability matrix and playacting practical risk assessments for GMP vital needs Author Traceability matrix and playacting practical risk assessments for GMP vital needs. Draft user demand specifications (URS), outline reports, and traceability matrix for Cell process instrumentation like -20ºC Freezers, -75ºC Freezers, LN2 Freezers, cold Centrifuges, Tube Sealers, Tube Welders, Particle Counters, Nucleo-Counters, photometer, Vi-CELL BLU, Controlled Rate Freezers, Thawing Device, Flow Cytometer, Cell Count & Viability instrument and Spinning Membrane Cell Washer Address & Draft deviations once the take a look at results didn’t meet the acceptance criteria throughout Installation and Operational Qualification and perform root cause investigation & impact assessment, implementing corrective actions, and documenting the justification for acceptance once implementing corrective actions. Perform Installation and Operational Qualification (IOQ) of Cell process Unit Equipment’s in Production, Warehouse/Storage space, QC, and Bioassay. Participate in sterile method Validation of producing processes. Offered salary $80,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.

Executed receipt of Drug Safety phone calls and complete phonephone AE type Created telephony communication logs into the info and sorting of cases PRN. Implement and dead QC on key fields of significant cases Executed case assessment (review events, confirm labeledness, establish co-manifestations, review committal to writing, confirm relation Created clear laconic clinical case narratives, review and updated auto-narrative PRN. Created company pharmacovigilance comments for relation assessment, dechallenge/rechallenge determinations and performed event rankings. Perform case handling together with receipt, book-in, assessment, duplicate-check, seriousness, expectedness, case process, Narratives, Follow up’s, Quality check and Submissions. Review and method device cases, test cases, and potential proceeding cases received from totally different sources. Perform correct committal to writing of Adverse Event and products for all incoming serious and non-serious cases victimisation medical nomenclature via MedDRA (Medical wordbook for restrictive Activities) and UN agency Drug wordbook. Quality review of ICSR’s concentrating totally on Narratives, Product committal to writing, Medical committal to writing for any attainable discrepancies with the connected supply documents and causing reports associated with identical to the involved product managers and case processors. Electronic coverage (E2B) of all necessary reports, accelerated safety reports, guaranteeing winning timely submission and collating acknowledgments of ICSRs from restrictive Authorities and Business Partners. Determined follow-up wants for AE reports. Reviewed and updated generated follow-up letters as acceptable Leveraged skilled background in pharmacovigilance to support Quality Assurance through reviewing documentation, shopper agreements, and restrictive pointers. Maintained data of company/client product safety profiles and producing processes to retort to all or any medical and technical inquiries associated with pharmacovigilance.Offered salary $80,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.

The Clinical information Manager can support the information Management cluster from study start-up through info lock and clinical study report exploitation EDS and applied math tools. The made candidate can deliver top quality information, on time and on budget. during this role, the candidate are expected to steer and supply oversight for the execution of knowledge management activities for quite one compound during a therapeutic space.Design and develop electronic Case Report Forms (eCRFs) for Inform info throughout study start-up activities. Conduct demand workshops with key stakeholders to gather the opinion on what information will be collected and the way it ought to be collected within the electronic case report style of the info Conduct surveys and receive the feedback from information management team & Clinical operations team on the report. Build and take a look at the Case report forms supported the finalized study necessities. Run Reports in InForm/J-review for information interpretation and analysis to spot question and SDV (source information verification) metrics. Create tables, listings and graphs with the topic information to confirm {the information|the info|the information} conformity with study protocol and determine data quality problems & trends. Work with the information stewards and correct the information quality problems.Offered salary $120,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.

Processing & coverage Adverse event into the merchandise Safety info for in association with Client’s Marketed and investigational product. Perform process and oversight of adverse event/drug expertise reports (serious and non-serious) and different safety connected information for marketed product and clinical trials Responsible for Adverse event cryptography victimization standardized nomenclature from a medical cryptography wordbook, like MedDRA To supportive the accuracy and completeness of data for every adverse event report that he/she is accountable in conjunction with the supply documents and making certain that the activities ar performed in a very manner in keeping with company SOPs. Assist in gathering Serious Adverse Events (SAEs) reports in a very timely manner within the preparation of each internal and external IND safety reports per company SOPs. Process all sorts of adverse event reports utilizing the protection info. Writing case narratives for serious, non-serious and study reports, quality/product criticism reports Medical cryptography into commonplace dictionaries and writing of narratives supported data provided each on commonplace forms and from medical records and different documents of diseases and medications. Responsible for taking acceptable selections by applying their information of FDA & ICH-GCP commonplace rules to put in writing over all case outline. Assist with literature review and article acquisition pro re nata Generate and work with different team members to send follow up letters or queries to the suitable communicator victimization the foremost expedient mechanism, forwarding to clinical sites wherever acceptable. Communicate/Collaborate with Medical Affairs (MA) Department in cases involving each Associate in Nursing drink and potential Product Quality criticism part.Offered salary $70,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.

Director Operations drives and leads the flourishing execution of all operational parts of a large-scale international program mistreatment robust project management, leadership and structure skills. Lead overall operations program/team liable for supervise Clinical Operations, restrictive Affairs, Compliance, Pharmacovigilance, Commercial, Marketing, Medical Affairs and Sales groups. Develop top quality business methods and plans guaranteeing their alignment with short-run and semipermanent objectives Accountable for operational execution to support a various portfolio of labor across Company. Proactively addresses and manages risks and issue increase Demonstrates proactive, money berth of company’s clinical programs whereas effectively leading an oversized international team of people allotted to the program. Lead and inspire subordinates to advance worker engagement develop a high activity social control team Oversee & Assess all operations and business activities to confirm they turn out the specified results and area unit according to the general strategy and mission Takes possession and answerability for the Development/management/reconciliation of overall operations among departments of Company Manages comes timelines, deadlines and budgets to incorporate negotiating contracts with To implement the organization’s strategic set up and lead the organization toward advancing its mission by making new revenue sources, innovative community partnerships and powerful programs Enforce adherence to legal tips and in-house policies to keep up the company’s lawfulness and business ethics Analysis of monetary and operational results versus forecast, plan/investigate important variances and communicate findings to follow leaders Developed and suggested annual & quarterly money objectives for the corporate. Offered salary $130,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.

The Quality Engineer is liable for guaranteeing the merchandise Life cycle/supply chain provides elements, assemblies, and merchandise that meet expected quality levels. the standard Engineer works cross functionally with Operations, Engineering, and Quality Organizations, to endlessly improve provider performance by implementing method controls and develop quality assurance plans. Plan, develops, and executes method and check methodology validations (IQ, OQ, PQ, PPQ) in accordance with company and pointers Responsible for active and aiding in guaranteeing company wide compliance with the standard System procedures and needs and lead the event of quality plans, CAPAs, provider qualifications and support verification and validations Creation of Electronic amendment Controls (ECOs) of Drawing, IPRs, Work instruction for initial unharness or doc updated Revision. Provide associate on floor support for examination methodology records, GD & T problems in Blueprints, BOM Issues, provider examination problems. Provides support on CAPA for prime risk (Directly Impacted) problems. Coordinate examination connected activities in support of different departments’ functions and needs as well as playing inspections or tests of purchased elements. Coordinate the news, analysis, and determination of fabric non-conformance incidences as well as active participation in Material Review Board and different conferences PRN. Support and coordinate provider connected quality activities to make sure continuing improvement. Perform inspections or tests of Adhere to style management procedures, general safety rules, company policies and procedures, smart producing Practices, and agency rules as well as the qualification and implementation of Document Changes Notices involving product or method changes.Offered salary $75,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.

The PV Submission Specialist, below lowest oversight, can assume the responsibility of reviewing and transmission of needed individual cases safety reports (ICSRs) for submission (paper and electronic) to international regulative agencies, business partners, affiliates and different destinations. Submission specialist can perform the reconciliation of submission dates and assist with website audit requests. should maintain continuous data and experience of native and international necessities for safety coverage. Prepare international submissions. Reviews regulative problems with supervisor, as necessary, and assists within the negotiation of submission problems with agency personnel Prepare native paper submissions to FDA in accordance with company processes Complete all on time submissions to all or any applicable coverage destinations Generate, Review, and Transmit to all or any schedule reports to international Health Authorities as well as however not restricted to FDA European Agencies, Health Canada, etc Generate CIOMS I kind, 3500 FDA MedWatch kind or like international partners supported outlined timelines Prepare CIOMS I kind could be a coverage kind, not primarily supposed for electronic exchange between databases, linking the CIOMS I kind offer by ICH-FDA. Monitors the security information for failing submissions. Offered salary $80,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.

Processing & coverage Adverse event into the merchandise Safety info for in association with Client’s Marketed and investigational merchandise. Perform process and oversight of adverse event/drug expertise reports (serious and non-serious) and different safety connected information for marketed merchandise and clinical trials Responsible for Adverse event cryptography victimisation standardized language from a medical cryptography lexicon, like MedDRA To verificatory the accuracy and completeness of knowledge for every adverse event report that he/she is accountable in conjunction with the supply documents and guaranteeing that the activities area unit performed in an exceedingly manner in keeping with company SOPs. Assist in gathering Serious Adverse Events (SAEs) reports in an exceedingly timely manner within the preparation of each internal and external IND safety reports per company SOPs. Process all sorts of adverse event reports utilizing the security info. Writing case narratives for serious, non-serious and study reports, quality/product criticism reports Medical cryptography into customary dictionaries and writing of narratives supported data provided each on customary forms and from medical records and different documents of diseases and medications. Responsible for taking applicable choices by applying their data of federal agency & ICH-GCP customary laws to jot down over all case outline. Assist with literature review and article acquisition as needed Generate and work with different team members to send follow up letters or queries to the acceptable newsperson victimisation the foremost expedient mechanism, forwarding to clinical sites wherever applicable. Communicate/Collaborate with Medical Affairs (MA) Department in cases involving each AN drinkable and potential Product Quality criticism element. Offered salary $70,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.

The primary purpose of this position is to guage, choose and apply commonplace engineering practices, techniques and procedures whereas exploitation judgement once creating diversifications and/or modifications to machinery, check and activity instrumentality and/or systems. Ensures company’s internal and external client expectations square measure met or exceeded. Plan, develops, and executes method and check technique validations (IQ, OQ, PQ, PPQ) in accordance with company and tips Design management systems to coordinate activities and production coming up with so as to confirm that merchandise meet quality standards Figure out a way to manufacture elements or merchandise, or deliver services, with most potency Development and implementation of investigations, protocols and check standards, procedures to take care of needed Follows and develops Quality and regulative necessities together with Company’s policies, procedures, and acceptable regulative necessities Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness exploitation common Company’s engineering tools & templates wherever on the market, (Examples embody specifications, producing procedures, ECOs, and technical reports or analysis) Applies and promotes Lean producing techniques to ceaselessly improve cycle times and method flows. Identifies, supports, or directs the execution of improvement efforts to scale back waste all told producing and business processes Support and Participate within the lean producing cultural modification to drive out waste in producing processes Program knowledge validation checks and listings to spot production discrepancies. Offered salary $80,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.

Reviews the Adverse event case narrative, coding, product/Indication, labeling in accordance with the several reference safety documents, relation and anamnesis for medical completeness, accuracy, and overall medical content. Analyze medical information to analyze causes and treatment of toxicity, pathogens, or chronic diseases and adverse event reaction caused thanks to medication given for medication. To Review and supply PV therapeutic space input for development of protocols, IBs, SAPs, CSRs and alternative relevant project/study documents Review a Line Listing of cases and evaluates the writing and labelling and make sure the events ar evaluated properly. Manage review of cases per internal timelines In conjunction with pharmacovigilance scientists and physicians contribute to writing and maintaining Risk Management Plans. Contribute to finding reconciliation medical writing issues/discrepancies Review and update generated follow-up letters for the prescribers and investigators as applicable. Responsible for Company sponsored clinical trials, confirms that a case may be a SUSAR case or Associate in Nursing otherwise expeditable report which needs unblinding Responsible to support in getting ready combination safety information reviews for pre-and post-marketing ASRs together with Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk analysis Reports (PBRERs), Periodic Adverse Drug expertise Reports (PADERs), Development safety Update Reports (DSURs), IND annual reports, and alternative Ad-hoc reports Liaise with promoting team(s) to judge safety impact and supply input into program style (e.g., social media, marketing research, patient support programs). Assist in writing and/or reviewing of monthly safety signal reports. Offered salary $135,000 P/Y. Mail resume with cover letter to Globex Pharma Inc., 51 Cragwood Road, Suite 304, South Plainfield, NJ 07080.