Associate Director, PV Ops – Optimization and Engagement

2 weeks ago

bangalore, India 14260 GSK India Global Services Private Limited Full time

Key Responsibilities

Contribute to creation or development of PV Ops processes and written standards

Collaborate with stakeholders (e.g., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operations/Sciences/Development) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.

Work across a complex matrix environment to ensure compliance with internal standards and external regulatory requirements

Where process or training issues are identified, facilitate investigation into root cause, creation of corrective/preventative actions (CAPAs), and support with remediation of process/training needs

Review and maintain oversight of PV Operations training materials

Work with content owners and experts to prepare internal and external presentations as required

Implement changes to PV Ops training curriculums in line with current PV Ops structure and maintain oversight of PV Ops training aspects

Manage PV Ops Optimisation mailboxes for responsible workstream and respond to allocated queries in a timely manner.

Facilitate, where required to assess the impact of changes to Pharmacovigilance regulations and track implementation of changes required

Track and oversee regulatory enquiries sent to PV Ops, ensuring appropriate, thorough and timely responses

Coordinate appropriate archiving, in line with GSK Global Archiving processes, ensuring the successful retrieval of documentation and supporting inspection-readiness

Where problems or issues are identified, escalate to PV Ops Optimisation Manager / Director, as appropriate

Generate new ideas and proposals for global implementation; contribute to advancement of PV Ops methodology and optimization of processes.

Coordinate PV Ops involvement in audits and inspections

Demonstrate GSK values

Ensure appropriate prioritisation and time management, in line with business needs

Build external relationships with key stakeholders and senior leaders

Ensure relevant PV OPS Optimisation-related oversight to the (PV OPS) Directors

Resolve issues and concerns within the PV OPS Optimisation team and where resolution is not possible or there is impact across PV OPS escalate to PV OPS Optimisation Director,

Ensure PV OPS Optimisation activities are appropriately resourced and escalate any resourcing issues

Develop and identify training requirements and establish a required training plan for individuals

Provide workload forecasts to PV Ops Directors and work with Director to strategically plan, in line with business goals

Use influencing skills to drive best practice and innovation across PV Ops

Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub teams

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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