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).