- Ability to work in multi-matrix and multi-cultural teams across diverse time-zones and network across diverse geographies
- Ability to negotiate, resolve conflicts, prioritize, and organize in a complex environment
- Lead and manage projects in terms of people, client and operations management
- Lead and monitor performance of individuals within teams for maintaining excellence and highest level of governance and compliance
Johnson & Johnson as Senior Manager PV CAPA : Feb 2018 – Present
As a Compliance Strategy and Analytics Lead, I provide CAPA process oversight of PV Deviations and CAPAs associated with audit and inspection findings across the Consumer and Pharma sectors of J&J in support of End-to-End PV (Pharmacovigilance) CAPA Management process.
- Oversee the kick-off and execution of activities required for PV CAPA management with the Business Function in coordination with QA auditor or BRQC Regulatory Compliance as applicable.
- Liaise with business stakeholders through CAPA Lifecycle management.
- Review findings and makes recommendations for Corrective Action plan to ensure robust CAPA that eliminates recurrence of noted issues.
- Communicate, coordinate, and escalate as needed all activities associated with completion of the investigation or CAPA as per committed timeline. Track progress against schedule and manage multiple concurrent activities and stakeholders.
- Monitor and assist with reporting and oversight activities, including trending analysis to the relevant business stakeholders, as required for Governance forums.
- Contribute directly to the approval of compliance strategies required to remediate deviations and observations from audits/inspections.
- Direct teams of stakeholders and subject matter experts through the process of investigation and CAPA development to ensure that deliverables per the defined process are understood and delivered by the owners as required.
- Review KPIs of the Audit and Self Identified records coming from the team to ensure they meet the desired quality
GlaxoSmithKline Pharmaceuticals Pvt Ltd. as Global Quality and Risk Management Manager: Apr 2015 – Feb 2018
Quality and Risk Management Manager: To lead and deliver an effective Medical governance and risk management framework within the Classic and Established (CEP) Team of GSK by:
- Ensuring compliance to company’s policies and procedures for the entire CEP team
- Implementing the Internal Control framework for the CEP team and set up controls for the different elements of the framework
- Implementing management monitoring for the team covering the high risk areas within the group to ensure identification of any gaps in the processes. Ensuring timely CAPA closures and making sure they are effective
- Involving in the Risk Management activities
- Work on a Risk Register with the GM and other therapeutic area heads to capture the key risks in their TAs, devise treatment plans for the same and ensure implementation
- Partner with the Compliance to support implementation of new or enhanced controls to mitigate identified and emerging risks
- As a part of the Quality Review Committee (audit Task force), identifying and delivering opportunities for continuous improvement of various processes within the team
- Develop and implement risk assessment tools that will support service and practice monitoring whilst encouraging high quality deliverables
- Contributing to development of best practice documents, guidelines and training manuals as needed
- Carrying out internal assessments/audits on key processes on the team to ensure compliance and inspection readiness.
- Produce regular reports which demonstrate the quality of work and compliance levels within the team.
- Actively lead and engage with team members to monitor outcomes and put effective measures in place for improvement for results
- Single point of contact for external audits and oversee &review trends in line with audit outcomes, risk assessments
GlaxoSmithKline Pharmaceuticals Pvt Ltd. as Global Medical Information Manager: June 2014 – Apr 2015
Global Medical Information Manager: Managing and leading the Medical Information group to produce high quality scientific responses in a timely manner
- Leading and Managing delivery of projects in terms of resourcing, quality, timelines, efficiency and compliance to Standard Operating Procedures for deliveries made by Medical Writing group/Third Party Vendors.
- Lead the management of third party vendor involved in development of Medical Information responses for GSK products covering the Anesthesia, Anti-Infectives, Neurosciences, Hepatology, and Allergic Rhinitis portfolios across EMAP&J and EU
- Overall accountability to ensure timely delivery of highest quality MI
- Workload distribution and resource planning
- Development and implementation of controls to ensure high quality and compliance to MI standards
- Accountable for the management of the Medical Information Global Database
- Stakeholder Management:
- Work closely with the GSK Medics and GSK Local Operating Companies globally to ensure seamless efficient support to HCP inquiries
- Liaising and working with the other stakeholders within the company such as Regulatory, Manufacturing, Clinical R&D etc and maintaining good working relationships with them
- Act as an SME and engage with Medical Information teams across EMAP and Europe and training them on their Medical Information needs
- Building capabilities and understanding of Global Medical Information across Emerging Markets, Asia Pacific, and Japan (EMAP&J) region and EU.
- Partner with MI director in planning regional medical information forums to build awareness and reinforce compliance
- Accountable for Monitoring performance and oversight and ensuring team is sudit ready at all times
- Act as a Medical Information SME for other functions
- Comply to highest ethical standards and medical governance requirements
- Develop working practices/standard operating procedures in cohesion with internal/customer functional leads to be used internationally across EMAP and EU
- Take a lead on key projects for the Global Medical Information Department and coordinate with interdisciplinary partners as required
- Global Employee Recognition Award for end to end delivery of the HCP HUB model and arranging for a knowledge sharing session for the CEP team, thereby addressing and mitigating the existing gaps owing to system and people changes
- Global Employee Recognition Award for enhancing efficiencies with the Third Party Vendor and simplifying the Outsourcing model for CEP
- Global Employee Recognition Award for setting up the Internal Control Framework and taking on other quality initiatives on top of the Medical Information role
Sciformix Technologies Private Ltd., from Dec 2011- Present as a Medical Writer and Project Coordinator
- Carrying out medical literature searches.
- Provide guidance to Narrative Writing and Medical Writing Teams.
- Guide teams on client expectations and ensure they meet them to the highest standards
- Handling the label updates and updating product labels in various markets.
- Writing CSR narratives, clinical and spontaneous case narratives including summaries and ICSRs.
- Writing and editing scientific manuscripts and peer reviewing manuscripts.
- Preparation of medico-marketing documents such as product monographs for pharmaceutical products such as training manuals and training slides.
- Monitoring the quality of work produced by the case processing team and implementing quality improvement initiatives as appropriate.
- Facilitating training and providing feedback for overall team excellence.
- Providing technical assistance to the case processing team and writing team whenever required.
- Maintaining relationship with the client and acting as the primary point of contact to ensure smooth functioning of the project.
- Managing team members – ensuring timely deliverables and maintaining quality checks.
- Assisting in the creation and maintenance of invoicing sheets of various projects, FTE allocation, etc.
- Coaching, mentoring, training and development.
- Help identify quality metrics and implement according to plan
- Implementing efficient quality measures to meet timelines, productivity and quality of deliverables.
- Roll of honour award for May 2013 for excellence in end-to-end execution of a project
- SMART award to the entire team I was leading for their performance
- Star Award for December 2013 for leading and delivering a pilot project and winning a complete contract from the client.
Tata Consultancy Services Ltd., Feb 2007 to Dec 2011 as a Research Associate/IT Analyst
Project 1: Mumbai; Domain: Pharmacovigilance; Period: August 2009 – December 2011
Position: Pharmacovigilance Scientist
- Executed drug safety management process of spontaneous and clinical trial cases – case triaging, entry, narrative writing, labeling assessment, and causality assessment.
- Handled end to end process of literature cases: line-listing initiations, assessing validity, processing, single case assessment and performing quality checks for case validities.
- Performed other support activities such as training coordination, tracking metrics etc.
- Managed and maintained company defined quality and compliance while adhering to regulatory timelines for adverse event reporting.
Project 2: Hyderabad; Domain: Research and Development; Period: Feb 2007 to Aug 2009
Position: Researcher associate
- Developed a method to identify genomic islands in bacterial genomes.
- Carried out analysis of genomic islands across more than 400 fully sequenced proteobacterial genomes using this method.
- Analyzed the resulting islands and did a sub analysis to identify other islands such as pathogenicity islands, symbiotic islands, metabolic islands, etc.
- Identified type VI secretion system across 19 Gram negative bacterial species.
- Proposed a mechanism of action for the functioning of the system.
- Two publications as a primary author (given below)
- Pat-on-the-back award by the client for being the first to get signed-off for working independently on projects
- Pat-on-the-back award for delivering high quality literature cases and successful completion of the pilot project. Resulting in getting more business from the client and a full-time project for processing literature cases.
- Shrivastava S and Mande SS (2008) Identification and Functional Characterization of Gene Components of Type VI Secretion System in Bacterial Genomes. PLoS ONE 3(8):e2955 doi:10.1371/journal.pone.0002955.
- Shrivastava S, Reddy Ch V S K and Mande S S (2010) INDeGenIUS, a new method for high-throughput identification of specialized functional islands in completely sequenced organisms; J. Biosci. 35 351–364 DOI 10.1007/s12038-010-0040-4.