location_onHyderabad, Telangana, India
watch_later Posted: May 02, 2025
Job Description
Main Responsibilities
About you
Scientific background: M.Pharm, Pharm D or Master's Degree in Human Health or License Degree in Human Health Sciences
- 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 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.
- 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
- Validation tools (database, signal management tools)
- Experience in PV Audits and Inspection Management
- Good depth understanding of Quality Risk Management and Quality systems
Scientific background: M.Pharm, Pharm D or Master's Degree in Human Health or License Degree in Human Health Sciences
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