Immuno Act Job opening for Pharmacovigilance apply Now
JobDescription | |||
JobTitle: | Project Manager – Pharmacovigilance | ||
Function: | ClinicalOperation | Reportto: | Head clinical operation |
Location: | MIDC Rabale, Navi Mumbai | PositionType: | Full Time |
AboutImmunoadoptive Cell Therapy Private Limited: | |||
ImmunoACT is a pioneering cell & gene therapy company, currently in Phase II trials for India’s first indigenously developed CAR-T therapy for the treatment of refractory/relapsing B-cell malignancies (HCAR19), with an aggressive pipeline to treat liquid and solid tumors, With strong, strategic Research (IIT-Bombay) and Clinical (Tata Memorial Hospital) collaborations, ImmunoACT is paving the way towards affordable and accessible gene-modified cell therapies for resource-constrained economies. Our first state-of-the-art GMP facility has been operational since mid-2022, as we scale-up and scale-out our production capabilities to serve the clinically unmet needs of patients across India.  OurVision: To be a Leader in Cell & Gene Therapy for the Long-Term Cure of Patients, through Translational Research in India & beyond
OurValues: ·        Accessible and affordable to all ·        Cutting edge research ·        Transforming ideas to reality
Become apartofthisrevolutioninthe healthcareindustry – growyourcareerwithus.Website–https://www.immunoact.com/-Visitourwebsite,understandaboutus. LinkedInProfile–https://www.linkedin.com/company/immunoact/
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RolesandResponsibilities | |||
·        To build a good understanding of the Indian oncology space, cancer-site-specific patient burdens, operational details of the CART treatment and patient requirements. ·        To maintain and expand on partnerships with clinical team members of treatment centers, their administration, and auxiliary personnel – with the goal of providing expanded access to CAR-T therapies to patients and ensuring smooth clinical operations. ·        Maintain awareness of current state of cell & gene therapy (literature and competitive intelligence) and provide critical evaluations on the clinical operations.​ ·        Build and lead a team of executives for each of the current hospitals in their zone. ·        Lead and coordinate internal and external PV audits and inspections. ·        Monitor PV system performance and compliance of partners and distributors ·        Act as the responsible contact person in the region, internally and externally, for safety-related aspects and PV. ·        Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities. ·        Perform other duties as assigned. |
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Key Performance Indicators | |||
·        Meeting the clinical readiness of the site/hospitals ·        Meeting regulatory requirements as per GLP/hospital ethics guidelines ·        Training of the hospital personals (nurses/ other staff) on CAR-T products infusion and management ·        Positive satisfaction ratings from the clinical/hospital teams). ·        Leadership qualities in terms of training and motivating direct reportees ·        Stakeholder management internally and externally.  |
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QualificationsandEducationalRequirement | |||
·        Masters in Clinical Research/PG Diploma in Clinical Research
·        3+ years of extensive, hands-on clinical trial and/or clinical settings of sponsor product ·        Experience with international and domestic regulatory submission, oncology experience, clinical trial experience |
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DesiredQualities | |||
·        Domain expertise in Cell Therapies, CAR-T, biologics manufacturing is plus.
·        Excellent verbal, written, presentation and interpersonal skills. ·        Strong analytical and problem-solving skills. ·        Proactive, creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks. ·        Strong analytical and problem-solving skills. ·        Excellent written and verbal communication skills. ·        Ability to work independently and as part of a team. ·        Ability to manage multiple projects simultaneously. ·        Strong attention to detail. ·        Ability to work under pressure. |
Compensation | Compensationandotherperquisiteswouldnotbeaconstraintfortherightcandidate |
EmailId | [email protected] |
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