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Head-Clinical Research and Pharmacovigilance

12.00 to 20.00 Years   Panchkula   22 Mar, 2022
Ind Swift Labs
Job LocationPanchkula
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    Job Summary:The person will be accountable to lead the overall execution of clinical research along with drug safety functions during the entire drug development process and post marketing period.Roles and Responsibilities :1. Co-ordinate closely with the Formulation Development and other cross-functional representatives, including Biostatistics, Regulatory, QA, Project management etc.2. Scientific input in product development and meet the regulatory requirement:3. PK and Statistical data interpretation using Phoenix WinNonlin/SAS or equivalent software to decide future course of development.4. Provide medical expertise during clinical research and drug development:Advise on trial related medical questions or problems and Safety management,5. Presentation and communicate with IEC/IRB/Regulatory authorities as company representative for applicable clinical activities.5. Management of Pharmacovigilance functions for the company:6.Trial originated Adverse Drug Reaction assessment ReportingEngagement of QPPV, partners, maintaining PSMF and Hosting regulatory inspections for Pharmacovigilance function of the company.6. Outsourcing of Activities and management7. Assist in developing and overseeing the implementation of CAPA in relation to audit or regulatory inspections and ensure lessons learned are developed and shared9. Support the company regulatory team for timely and appropriate notification/Submission to Regulatory Authority (ies).Desired Candidate Profile- MBBS/masters in pharmacy/PhD or equivalent degree in life Sciences.- 15-20 years of work experience in various capacities of clinical research and Pharmacovigilance in CRO and Pharmaceutical Company.Perks and BenefitsBest In Industry,

Keyskills :
safety managementclinical researchdrug safetydrug developmentdata interpretationproduct developmentproject management

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