Pharmacovigilance QA Auditor

Sun Pharmaceuticals, Inc; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a Pharmacovigilance QA Auditor to assist in auditing programs and ensuring adherence to quality standards. Ideal candidates will have a Post Graduate in Pharmacy or BDS and around 2 years of relevant experience. Responsibilities include conducting audits, managing internal audit observations, and preparing SOPs. The company emphasizes employee well-being and offers robust growth opportunities.

Benefits

Robust benefits

Opportunities for personal and professional growth

Qualifications

• Around 2 years of experience in Pharmacovigilance Quality Assurance or Signal management.

Responsibilities

• Assist in developing global Pharmacovigilance system auditing program.
• Conduct and report audits for outsourced parties.
• Review and close deviations raised at global and regional levels.
• Prepare and review departmental SOPs.
• Support operations team during corporate audits.

Skills

Auditing skills

Attention to detail

Good spoken and written English

Liaising with different teams

Education

Post Graduate in Pharmacy (M. Pharma) OR BDS

Job description

Overview

Title: Pharmacovigilance QA Auditor

Business Unit: R&D Quality

Job Grade Executive / G12A

Location: Gurugram, H.R.

Responsibilities

• 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 associated 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

Estimated: 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

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Lets 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).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.