Main responsibilities:

• Perform the QA review of the ICSRs, PBRERs, Signal/Safety governance activities and literature screening output against the applicable source documents/versions

• For ICSRs

• • Quality Review of ICSRs in PV Safety Database against all the relevant source documents of an assigned case version or previous case versions when required

  • Categorizing and updating the ICSR QA observations

• For Signal

• • Review of Signal/Safety governance activities in related tools/platforms

  • Finding out the discrepancies and categorizing these observations into critical, major or minor findings

• Ad hoc: Literature, PSR/RMP should be reviewed as needed.

• • Quality Review of literature screening output in a related tool and identifying the discrepancies against the literature articles or abstracts.

  • Finding out the discrepancies in the PBRER against the source documents and categorizing these observations into critical, major and minor findings. Preparation of de-brief memo for internal stakeholder circulation for PBRER QA

• Check consistency between other PV docs such as, PVA and related reporting rules.

• • MA Retrospective Review), QC reporting rules, SMART QC, Audit Inspection, QC data My Alliance

• Send out the observations to the respective stakeholders for obtaining root cause analysis (RCA) for the observations

• Follow up for obtaining corrective/preventive action (CAPA) for the observations

• Review and finalize RCAs & CAPA

• Peer review of ICSRs, Signal/Safety Governance Activities and Aggregate Reports (PBRERs) against the applicable source documents and updated checklist and applicable tools.

• Preparation and Presentation of the data to the responsible stakeholders in an appropriate forum as required.

• Preparation of de-brief memo for internal stakeholder circulation for PBRER QA

• Resolve QA finding disagreement between the QA team and case processing teams

• Plan and perform training session to newly recruited staff and refresher training as and when needed

• Manage & provide monthly and quarterly project related metrics

About you

Experience:

• Experience in the Pharmaceutical or Biopharmaceutical industry, ideally 5+ years in consumer healthcare pharmaceutical industry.

• Minimum of 5 years of experience in ICH-GxP-related Quality operations and Compliance, of which 3-4 years’ experience in PV, is mandatory.

• Knowledge of international regulations/Guidelines/Good Practices pertaining to the ICH-GxP

• Good in-depth understanding of Quality Risk Management and Quality systems

• Thorough knowledge of ICSR case management, Signal management, Literature, and PSR process. Ability to evaluate RCA and CAPA for similar activities.

• Knowledge of KPI and its calculation, will be preferred.

Soft skills:

• Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.

• Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.

• Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.

• Excellent team-work and interpersonal skills

• Ability to work in cross-functional teams

• Excellent oral and written communication skills

Technical skills:

• Validation tools (database, signal management tools)

• Experience in PV Audits and Inspection Management

• Good depth understanding of Quality Risk Management and Quality systems

Education:

Scientific background: M.Pharm, Pharm D or Master's Degree in Human Health or License Degree in Human Health Sciences

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