Immuno Act Job opening for Pharmacovigilance apply Now

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.

LinkedInProfilehttps://www.linkedin.com/company/immunoact/

 

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.

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.

 

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

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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