CHETNA VATS
Gurugram
Summary
Experienced Drug Safety Operations Lead with over 11 years of experience in Pharmacovigilance. Looking forward to contributing to team success through hard work, attention to detail and excellent organizational skills for the development of the organization through my hard work, dedication, and positive attitude
Overview
12
12
years of professional experience
1
1
Certification
Work History
Drug Safety Operations Manager
Qinecsa
Mysore
05.2021 - Current
- As a Project Manager I provide business and execution leadership for one or more projects, holding accountability for project schedule, budget, risks, and interacts with all functions and levels of management ensuring effective communications
- Managing the project teams through the identification, justification, prioritization, initiation, development and implementation processes and to define the milestones to achieve the launch date commitments and identify issues and risks associated with those plans
- Accountable for project team performance, project schedule and execution, budget commitments and spend
- Managing team in defining project strategies, developing goals, and ensures project scope is defined and controlled
- Continuously interacts with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders
- Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes
- Leads core team to identify and implement continuous improvement
- Provides oversight and guidance on organizational goals and company objectives
- Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan
- Works with Finance to ensure appropriate customer invoicing, where required
- Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues
- Participates in the management of the Safety and Pharmacovigilance department with the following actions: - Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs), SMPs, PMPs and reports like DSURs
- Involved in the Bid defense meetings demonstrating the skills and expertise of the team and tools with the organization
- Part of a CoE (center of excellence) team
- This team is a group of SMEs from respective areas of expertise who guides and train the other members of the organization
- Participates in quality investigations and implementation of corrective and preventive actions.
Senior PV consultant
Syneos health
Gurgaon
08.2015 - 05.2021
- Lead and manage the project to comply with the SOW and SLAs
- Strong interpersonal communication skills; Strong problem solving skills
- Responsible for the identification, preparation, and delivery of any necessary training to Safety team members
- Managing resourcing's needs/issues and escalating to senior management as necessary
- Participates in audits/inspections and ensures inspection readiness
- Project management: managing daily deliverables, work allocation, team issues
- Monitor all case processing related activities to facilitate oversight on quality and compliance of deliverables
- Provide coaching and mentoring to all case processors
- Lead/Support the process changes according to internal and external drivers and monitoring of process related matrix
- Support in audits/inspections as subject matter experts and develop and implement corrective and preventive actions to address safety findings
- Develop, contribute and maintain process related documents such as Safety management plans and Project management plan
- Timelines, proactive workload management, resources & service level agreements (SLAs).
Senior Drug Safety Associate
Inventiv Health
Pune
07.2013 - 07.2015
- ICSR processing on Argus databases
- Quality assurance of ICSRs
- Keeping control over the QC aspect for the team
- Supports the team members in review of Drug Safety (Pharmacovigilance).
Drug Safety Associate
Covance
Pune
10.2011 - 06.2013
- Literature monitoring using different databases like Embase, EBSCO, and PubMed
- ICSR processing on Argus, Eudravigilance, and PV Net databases
- Quality assurance of ICSRs
- Keeping an account of the cases received from the site either in the inbox or fax - account, triaging them and sending to the safety team.
Education
Bachelor of Dental Science -
Bharti Vidyapeeth University
Skills
- Managing Meetings, Presentations, Processes and Project management, Quality assurance, Safety Team management, Workflow, Verbal and written communication, Microsoft Office proficiency
Certification
2011, PG Diploma in Clinical Research and PV, Institute of Clinical Research India, Delhi
Confirmation
I confirm the information provided is accurate and complete. Chetna Vats
Timeline
Drug Safety Operations Manager
Qinecsa
05.2021 - Current
Senior PV consultant
Syneos health
08.2015 - 05.2021
Senior Drug Safety Associate
Inventiv Health
07.2013 - 07.2015
Drug Safety Associate
Covance
10.2011 - 06.2013
Bachelor of Dental Science -
Bharti Vidyapeeth University