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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