Arpita Jindal

Experience

• 

  SGRRITS

  Sept 2011 - Dec 2013

  Clinical Pharmacist (Intern)

  M.Pharm in Clinical Pharmacy

• 

  Freelancer

  Jun 2013 - Dec 2019

  Freelancer Content Writer and SME

  Online Websites: • Re-writing already published news articles (Plag-free contents), articles on health benefits of fruits and vegetables, clinical updates, and tutorial articles on Clinical Research and Pharmacovigilance updates.Newspaper: Amar Ujala• Hindi articles on health-related issues and benefits.Kogent Learning Solutions, New Delhi:• Subject Matter Expert for MBA Books on Hospital Architecture, Planning and Management and Hospital Environment and Management in collaboration with Pondicherry University.BDK Life sciences Pvt Ltd:• Lead Content Writer and Project Manager. Show less

• 

  Accredited Consultants Pvt. Ltd.

  Dec 2013 - May 2014

  Technical Regulatory Associate

  • Worked for several multinational clients. • Responsible for preparing, reviewing, submission and getting approvals for various companies through FDA authorities on their behalf in the following fields:• Test License (Form 12).• Import License (Form 10).• Registration of Medical Devices, Diagnostic Kits and Drugs (Form 40).• Registration of New Drugs (Form 44).• Registration of Cosmetics (Form 43).• GS1 Registration for Bar Codes.• NOC.

• 

  Wipro

  Oct 2014 - May 2017

  Drug Safety Associate

  • Involved in pilot project set up• To response to medical information, query, product quality complaints, receive information adverse drug reaction reports through email, calls or fax etc.• Performing follow-ups to collect missing information.• Performing other support activities as assigned tracking various types of matrix ongoing QC of defined process steps, training, reconciliation of data from multiple sources as email, fax etc.• Assessment of seriousness, expectedness and causality based upon source document information, determine MedDRA coding of adverse events and there ranking and appropriately flag seriousness criteria• Resolution of queries of team members related to the medical terminology on day-to-day basis and also provide subject matter expertise as and when required.• Writing safety narrative which involves all essential medical details of case• Training and mentorship of the data entry personnel as and when required.• Attend regular training sessions and develop capabilities on an ongoing basis.• Maintain necessary peer client communication related to case processing. Show less

• 

  APCER Life Sciences

  May 2017 - Jun 2021

  • Monitor workload and allocate resources appropriately along with daily allocation of cases based on priority for regulatory submission.• Preparation of weekly and monthly minutes of meeting (MOM).• Preparation of RCA and CAPA for team’s error or escalation received.• Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate.• Develop and maintain expertise and knowledge of: all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.• Promote/participate, as appropriate, in internal and external safety activities• To actively participate and contribute in team meetings, process meetings, floor activities and new transitions.• To manage new transitions and contribute activity to the smooth transition and training of staff to handle new work efficiently.• To communicate with the client by addressing to the correct person, by responding in a timely manner, escalating in right time, following up the issues and reporting the status to the Manager.• To co-ordinate, the knowledge transfers process from Client to the team members.• To get signed off on all activities as agreed with the Client & implement sign off process for the team members as agreed with the LM.• Conducting effective meetings and calls with clients.• Maintaining the track of cases amongst the team.• Client interaction for queries, discussions, and trainings• To manage leaves within the team and ensure smooth management of daily work• Onboarding of new joiners and Off-boarding.• Training of entire team on new updates and training of new joiners. Show less • Monitor workload and allocate resources appropriately along with daily allocation of cases based on priority for regulatory submission.• Preparation of weekly and monthly minutes of meeting (MOM).• Preparation of RCA and CAPA for team’s error or escalation received.• Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate.• Develop and maintain expertise and knowledge of: all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.• Promote/participate, as appropriate, in internal and external safety activities• To actively participate and contribute in team meetings, process meetings, floor activities and new transitions.• To manage new transitions and contribute activity to the smooth transition and training of staff to handle new work efficiently.• To communicate with the client by addressing to the correct person, by responding in a timely manner, escalating in right time, following up the issues and reporting the status to the Manager.• To co-ordinate, the knowledge transfers process from Client to the team members.• To get signed off on all activities as agreed with the Client & implement sign off process for the team members as agreed with the LM.• Conducting effective meetings and calls with clients.• Maintaining the track of cases amongst the team.• Client interaction for queries, discussions, and trainings• To manage leaves within the team and ensure smooth management of daily work• Onboarding of new joiners and Off-boarding.• Training of entire team on new updates and training of new joiners. Show less

  • Team Lead

    Apr 2019 - Jun 2021

  • Senior Pharmacovigilance Associate

    May 2017 - Apr 2019
• 

  IQVIA

  Jun 2021 - now

  Associate Manager

  •Implement and support operational decisions as determined and instructed by senior management. •Subject Matter Expert (SME) and SOP Review.•Retention, Engagement, training, processes and assist in implementation for measuring and improving employee engagement local and/or global actions. •Supervise Safety Operations staff in accordance with organization’s policies and applicable regulations. •Include planning, assigning, and directing work, performance appraisal•Rewarding, disciplining employees, addressing employee relations issues•Assist with training professional and career development.•Identify training and development needs of staff in collaboration with Training team and Safety Management.•Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure.•Instruct and lead direct reports in efficient management of project budgets through effective timesheet reporting. Work closely with operations specialist managers.•Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets. Assist with meeting department utilization and realization targets.•Ensure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, work instructions and client expectations.•Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Work Instructions and project instructions.•Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables.•Support or Lead change management initiatives•Effectively able to manage People issues•Responsible for ensuring 100% compliance towards people practice and Processes•Responsible for filing and writing deviations for impacted cases, analyze root cause, and CAPA Show less