Process Compliance & Risk Mitigation Manager

4.00 to 7.00 Years Hyderabad 26 May, 2019

Job Location	Hyderabad
Education	Any Graduate - Any Specialization, Diploma - Other Specialization
Salary	Not Disclosed by Recruiter
Industry	Pharma, Biotech, Clinical Research
Functional Area	Production , Manufacturing , Maintenance
EmploymentType	Full-time

Job Description

Lead the implementation of strategies and tools designed to identify and categorize risk within the pharmacovigilance system collaborating strongly with Quality Assurance (QA). Lead and support projects related to Safety Systems/ AQWA/ CAPA applications. Prepare reports documenting the outcome of risk assessments for the Process Governance and Risk Mitigation management team and escalate key findings to the Head Process Compliance and Risk Mitigation. Prepare action plans based on the results of risk assessments, coordinating with other global line functions as required. Manage CMO&PS deviations and quality incidents through coordinating and monitoring: Receipt of deviations and incidents. Entry in to Adaptable Quality Workflow Application (AQWA) Timely completion of investigations Implementation of appropriate Corrective and Preventative Actions (CAPAs) and availability of appropriate evidence Completion of effectiveness checks Timely closure in AQWA Work closely with QA and process owners to ensure appropriately detailed investigations are com-pleted and appropriate CAPAs and effectiveness checks are implemented. Collaborate with other Global Line Functions across Novartis Divisions, including QA, EU Qualified Person for Pharmacovigilance (QPPV), medical affairs and marketing to ensure implementation of CAPA and fulfilment of the worldwide regulatory requirements Prepare/maintain guidance documents and training material to educate CMO&PS associates on the deviation and quality incident process Monitor compliance of the CMO&PS organization to deviation and quality incident handling pro-cesses and standards and where deficiencies are identified develop and implement strategies to address these. Review feedback from Health Authorities or other external parties, which is within scope of respon-sibilities, prepare a response and integrate the feedback in to Novartis group policies and stand-ards as appropriate. Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the prepara-tion of responses to findings and the development and implementation of CAPAs. Train and mentor CMO&PS associates as well as associates from other Global Line Functions as needed on the .

Keyskills :
pharmacovigilance deviation capa quality assurance process compliance risk mitigation subject matter expertise report preparation

About Company

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.

Candidate Profile

Minimum requirements:PharmD, MSc degree in life sciences or equivalent. Fluency in English. Knowledge of other languages desirable. Minimum 4 to 7 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in project management and demonstrated abil-ity to lead working groups in a matrix environment . Ability to deal and interact with a wide variety of people at all levels. Strong organizational skills. Strong negotiation, presentation and communication skills, and ability to operate effectively in an international envi-ronment and across functions. Excellent analytical skills. Ability to mentor and coach.

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