Pv Vendor Oversight Professional

2 weeks ago

Bengaluru, India Novo Nordisk Full time

PV Vendor Oversight Professional

**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN-
**The Position**
- This Position mainly relies to develop and maintain a framework for PV quality oversight for the external vendors/CROs used in safety. The position requires a solid understanding of PV and quality KPI’s and agreements with vendors and ensures that all internal and external PV system performance KPI requirements are met. Plays an instrumental role in ensuring the success of the department by raising red flags when necessary, streamlining and optimizing processes, effective tracking, timely report generation and stakeholder management.- Proactively identifies new needs and priorities of stakeholders and prioritises work to meet the stakeholders’ and/or opinion leaders’ needs while maintaining a close relationship with the stakeholders. The role is responsible for developing and maintaining a framework for Global Safety oversight of external PV vendors / CROs to ensure adherence to Global Safety’s quality and compliance goals and PV system performance KPI’s, establishes escalation pathways for onboarded vendors and proactively engage with vendors and internal stakeholders in global safety and IO.- The role also supports sponsor oversight of ICSR processing by vendors including the review and monitoring of compliance through various monitoring reports and other oversight activities while ensuring implementation of effective corrective and preventative action plans. Ensures liaising with IO SO PV manager so that due actions are taken to identified issues in compliance with GS compliance framework.- Ensure that all tasks are performed in compliance with agreements in place.
- Communicating with QPPV office and affiliates to query and/or clarify the details related to deliverables and KPI.
- Participate in projects in Global Safety or in other parts of the organisation with impact in Global Safety processes.
- Actively participate in inspections and audits when required. Assist with procedural activities as required or requested.
- Proactively identify issues and challenges which may have an impact on all interlinked system and processes systems and processes. Ensure compliance with the training plan provided for the role.

**Qualifications**
- Graduation and/or post-graduation in life sciences.
- Good understanding of the quality and compliance frameworks within Global Safety.
- Global pharmacovigilance operations experience preferred ( minimum 5 years).
- Strong technical written, verbal, and presentation skills.
- Ability to work efficiently and collaboratively, in a fast-paced, team-oriented environment with individuals at all levels.
- Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
- Strong working knowledge of GVP regulations and guidelines.
- Preferable to have experience working with CROs and vendors.
- Experience in regulatory authority inspections.
- Knowledge of computerized systems is a plus.
- Proven track record working within a cross-functional team.
- Solid Novo Nordisk organizational understanding.
- Understanding PV system performance metrics and KPI

**About the Department**
- Global Safety Global Business Service (GS-GBS) was set up in 2010 as one of the hubs for safety case processing. We handle case processing and medical review of Individual Case Safety Reports from different sources (spontaneous, literature, solicited and clinical trials). We are additionally engaged in safety surveillance, safety medical writing, safety report submission, training, quality control of ICSRs, Argus configuration and maintenance, information technology quality assurance, training co-ordination and literature surveillance activities, including medical literature monitoring.**Working At Novo Nordisk**
- At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.**Contact**Deadline**- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize

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