Associate Director, PVASC

GSK India

14 - 20 years

50 - 65 Lacs

Bengaluru

Posted:1 hour ago| Platform:

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Skills Required

Procurement Change management Due diligence Process improvement Author Oncology Pharmacovigilance Licensing Operations Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

PVASC Author:

Demonstrates a good understanding with regards to how Business Development, Commercial and Legal teams operate
Demonstrates technical expertise in interpretation of PV regulations, SOP/GUIs, systems/database conventions, etc.
Responsible for co-ordination, end to end evaluation, negotiation, and delivery of Pharmacovigilance Agreements & Safety Clauses (PVASC) with Third Parties to ensure GSK can meet its drug safety and vigilance obligations and ensure Patient Safety
Responsible for leading internal projects relevant to PVASCs, change management and making significant contributions to enable or improve compliance with global regulatory requirements for drug safety and vigilance
Manage end to end PVASC activities with business partners. These activities include without limitation:
- Initiates, negotiates and revises PVASCs as required
- Accountable for collaborating with business development, legal and licensing partners to negotiate and ensure PVASCs are maintained per GSK policy and procedure
- Collaborates with the heads of various departments to support PV operational needs when implementing obligations from a PVASC or company integration
- Acts as the primary Third-Party collaboration contact on all matters relating to PVASCs for internal and external stakeholders
- Performs due diligence of Third Parties vigilance systems prior to PVASC negotiation
- Ensures compliance with worldwide PV, materiovigilance regulations, guidelines and industry practice
- Conducts routine reviews of PVASCs to ensure adherence with global requirements, GSK business practices and the terms/status of the commercial agreement
In depth knowledge of GCP, clinical safety documentation and reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements.
Implement, maintain, and improve processes in alignment with GSK policy to ensure that PVASCs are maintained throughout their lifecycle and to ensure that GSK and partners comply with the terms of executed agreements.
Ensure stakeholders in LOCs, clinical, business development, quality and other relevant groups understand and are aware of their obligations for PVASCs

PVASC Leadership Responsibilities:

Demonstrated project management skills operating in a global matrix environment
Providing respective team support consistently, efficiently and reliably delivering to regulatory requirements, third party commitments (implementation, maintenance and termination of PVASC) and organizational expectations and driving quality across the team.
Ensure team support is provided for consistently, efficiently and reliably delivering to regulatory requirements, third party commitments (implementation, maintenance and termination of PVASC) and organizational expectations and driving quality across the team.
Developing and sharing pharmacovigilance and technical knowledge and experience with team members
Identify cases of potential noncompliance with internal and external procedures and follow appropriate procedures to investigate and, where necessary, identify risks, appropriate corrective actions and prevent future issues
Participate in quality or continuous process improvement activities related to area of responsibility or as requested
Maintain good documentation practice and be the Point of Contact in case of inspection/audit.
Provide inputs and support to site head in meeting the high-level objectives and assist in designing vision for the team.
Accountable Safety and Pharmacovigilance Agreements (PVA) databases
Accountable for managing and tracking PVASC agreements and reporting KPI status against PVASCs periodically to Management
Deliver training and/or project support as required
Implement, maintain and improve processes in alignment with GSK policy to ensure that PVASCs are maintained throughout their lifecycle and to ensure that GSK and partners comply with the terms of executed agreements.
Delivering training and/or project support as required
Balance resource requirements across the portfolio and promote a pragmatic, flexible, focused approach to workload
Develop and share technical, pharmacovigilance, PVASC and PV systems knowledge and experience with team members
Aid in Inspections/Audit. Constructing root cause analysis for the findings, non-conformities and CAPA for the same
Aid team members with decision-making, problem solving and work prioritization; provide review and quality check support as required
Lead in quality or continuous process improvement activities related to area of responsibility or as requested
Maintain appropriate organizational networks
Recognize matters that affect corporate or agency policies and escalate issues with high business impact or risk.

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