HYDERABAD · FULLTIME
QPPV Office, Manager
Haleon
Hyderabad · onsite · Posted 4d ago
Sourced from
Undisclosed8–13 yrsfulltimeHyderabad
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Section · 01
About this role
Job Summary
Role Responsibilities
Qualification
Competencies Skills
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Support Haleon QPPV (Qualified Person Responsible for Pharmacovigilance) as required including but not limited to i) the management of EU/Global PSMF (PV system master file) ii) delivery of QPPV Office activities and ensuring QPPV oversight of global PV system, iii) acting as EV (EudraVigilance) Trusted Deputy.
Role Responsibilities
To ensure and enable compliant organization and robust inspection readiness by:
- Coordinating QPPV Office operations and delivering relevant QPPV Office activities, acting as EV Trusted Deputy.
- Coordinating EU/Global PSMF updates to ensure it is current and inspection ready. Maintaining the Summary of the PV System. Managing the requests for PSMF and the Summary of the PV System.
- Driving relevant management monitoring activities and having oversight of other controls (e.g. processes/standards, training, etc.) if appropriate.
- Establishing and maintaining appropriate structures and processes in assigned area and training identified stakeholders accordingly.
- Deploying and maintaining meaningful KPIs/metrics that enable monitoring and reporting on the effectiveness of the QPPV oversight/ risk management framework and control in assigned area as well as enable compliant organization and drive continuous improvement programs.
- Collecting and consolidating relevant information from PV/vigilance system stakeholders to support overall compliance and risk management.
- Coordinating QPPV oversight/ management forums (e.g. QPPV Oversight Meeting)
- Being the contact point between PV/ Vigilance system functions.
- Articulating and communicating QPPV Oversight principles/model within RD.
- Developing supportive materials (templates, training, etc) in assigned area to help relevant functions in delivering their responsibilities towards QPPV and PSMF.
Qualification
- Life Science (or equivalent) degree.
- Minimum 8 years of experience in RD functions (e.g. Clinical, Regulatory, Safety, PV)
Competencies Skills
- A broad scientific/pharmaceutical industry background with relevant experience in RD functions (e.g. Clinical, Regulatory, Safety, PV, etc.).
- Ability to effectively communicate at all levels (communication adapted to audience), and to influence, negotiate and partner with stakeholders.
- Self-motivated and quick learner who proactively shares knowledge and welcomes knowledge and feedback from other team members.
- Ability to challenge ways of working, bring new ideas and seek any opportunity for continuous improvement.
- Ability to adapt to changing business and risk environment.
- Ability to effectively organise work and prioritize/run several activities in parallel being in the meantime responsive to emerging request.
- Ability to work independently and proactively towards resolution of complex problems.
- Demonstrated project management skills and management of complex cross-functional activities.
- Agility to navigate through matrix organisation to remove silos, inefficiencies, ambiguity bringing clarity/pragmatic solutions.
- Agility with data (KPIs, metric), ability to identify relevant ones, analyze them and come up with meaningful report and relevant actions/continuous improvement.
- Agility with quality tools, GxP environment and IT savvy.
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
Quality ToolsAgileoffice operationsLIFESCIENCEpharmacovigilancevigilancePVpharmaceutical industryProject ManagementRisk ManagementoperationscompliancerecruiterPharmaceuticalShares
Section · Company
About Haleon
Haleon
Pharma
1.7k+
employees
2022
4 years old
Gurgaon / Gurugram, Haryana
India
₹15.4L PA avg
Avg at Haleon
About
A global leader in consumer health, providing scientifically-backed brands aimed at improving everyday health and well-being for consumers worldwide.
Industries
Pharma
Employee ratings
0 reviews
3.4/ 5
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