Pharmacovigilance Qa Auditor

Title Pharmacovigilance QA Auditor Business Unit R D Quality Job Grade Executive G12A Location Gurugram H R Key Responsibilities At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys JOB DESCRIPTION Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor co-auditor for outsourced parties CROs Service Providers Vendors Affiliates Partners etc associated with Sun Pharma Pharmacovigilance operations Assist in conducting and reporting audits for Sun Pharma sites associate with Pharmacovigilance activities operations to assure adequacy adherence with established Quality Systems Management of Internal Audit Observation Database IAOD with the perspective of sharing audit reports CAPA reports and observation of global impact with all internal regional PV sites across the globe and Global Pharmacovigilance To assure that the CAPAs are adequately addressed and closed To review and close deviations raised at global and regional levels in order to ensure adequacy of associated CAPA Responsible for review of Pharmacovigilance SOPs for completeness clarity and compliance to global regional policies and applicable regulatory regulations guidelines To prepare and review departmental SOPs To assist in monthly report preparation Management training and records of GPvP-QA team through LMS Support operations team during corporate audit external audits Collaborate with cross-functional teams to ensure quality standards are met across all pharmacovigilance activities Lead the assessment tracking of global actions and monitoring of identified actions as part of various corporate initiatives To perform any other responsibilities assigned with regards to the R D Quality system Maintain documentation and records in accordance with quality and regulatory standards Education and Experience Post Graduate in Pharmacy M Pharma OR BDS Around 2 years of experience in Pharmacovigilance Quality Assurance OR 2 years experience in PSUR Signal management Technical Competencies Auditing skills Attention to detail Behavioural Competencies Soft Skills Good spoken and written English Liaising with different teams Travel Estimate Low Job Requirements Educational Qualification Post Graduate in Pharmacy M Pharma OR BDS Experience Around 2 years of experience in Pharmacovigilance Quality Assurance OR 2 years experience in PSUR Signal management Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees as assigned to this job Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent s