Medha Chaphekar

More than 14 years of experience in pharmacovigilance, signal management, regulatory responses, aggregate reports, complex safety reports, benefit risk management activities, governance meetings, labelling, literature monitoring, medical writing, and clinical monitoring. Previous roles included leading literature monitoring project as a literature specialist, leading narrative projects as a medical writer, ensuring quality control in processing ICSRs, and monitoring and handling a multi-centric trial as a clinical research associate. Expertise in managing scientific literature and narrative writing projects from various clients, reporting and documentation of ICSRs, working on ARGUS safety database, mentoring new people in the team, co-ordination of domain and project specific trainings, and internal audits.

Additionally, have delivered lectures on various topics of clinical research.

Lean Six Sigma

Certified.

Safety Aggregate Report Manager at IQVIA (2019-01 – Present)

Supporting all PV activities for a product, or group of products in partnership with the Global Safety Officer (GSO) to evaluate safety data from multiple sources for assigned client's products.

• Handling client project administration activities, ensuring compliance of deliverables with the team, mentoring, guiding, management of workload, compliance of client KPIs, conflict resolution within team and across-teams, performance reviews, audit readiness.
• Managing ongoing core signal detection, and authoring periodic signaling reports along with the GSO.
• Co-ordinating, drafting and proposing responses to regulatory agencies or responses to inquiries from internal or external stakeholders in collaboration with the GSO.
• Acting as a Core member of the Safety Management Team (SMT), including end to end tracking for signals, involving in the validation/assessment, setting agenda, producing necessary data outputs, requesting contribution of all functions, preparing slide presentations, presenting in Safety Management Committee (SMC) when needed, facilitating discussions & documenting conclusions.
• Representing Pharmacovigilance on study teams, cross functional product teams, etc. when assigned as the delegate for the GSO.
• Performing end to end analysis and drafting of various safety reports (SER, Response to HA query/questions, HHE, OTC Switch, MRPTC, structured Benefit Risk Assessment etc.) in collaboration with GSO.
• Supporting the preparation and maintenance of safety sections of the Company Core Data Sheet (CCDS) as well as providing input and review of applicable section of aggregate reports (PBRER, DSUR).
• Collaborating with the GSO in preparation of risk management documents (DRMPs, RMPs and REMS).
• Maintaining and ensuring that the client KPIs are met by the entire team for routine signal detection activities.
• Mentoring new staff and conducting cross-team trainings when required.

Safety Aggregate Report Specialist at QuintilesIMS (2016-08 – 2019-01)

Responsible for performing Literature review activities and for writing literature sections of aggregate reports.

• Complying with all applicable service level agreements for Safety Aggregate Reporting and Analytics (SARA) deliverables.
• Serving as principal owner of the SARA deliverable and having responsibility for completion of the document in compliance with all applicable service level agreements.
• Preparing each version of the SARA deliverable and maintaining version control of the document.
• Requesting source documents from other Quintiles departments or customers.
• Addressing all review comments by both internal and external stakeholders.
• Attending internal and customer project team meetings (face-to-face, online or via teleconference) as defined in the scope of work (SOW) and budget.
• Leading projects and ensuring all activities are completed on time and meet quality standards.
• Facing internal and external audits.
• Mentoring newer staff members or conducting revision trainings for the team.
• Working closely with case processing service operations to resolve issues.
• Interfacing with other functional groups, such as Regulatory Affairs, Clinical/Medical Affairs functions, Quality, Information Technology, or other business units as needed.
• Assisting in preparation of function-specific responses to regulatory authority requests and of function-specific responses to assessment reports from regulatory authorities.
• Leading or participating in project teams and committees as assigned.
• Initiating new projects to improve processes.

Analyst – Medical Writing at Cognizant Technology Solutions (2014-11 – 2016-08)

• Study lead and Back-up lead for projects.
• Writing case narratives – Oncology and performing peer review of the narratives.
• Complete project management of the studies.
• Frequent client interaction.
• Maintaining Defect Trackers.
• Mentoring new writers.
• Responsible for organizing all necessary trainings, maintaining records, keeping team ready for training audit.
• Responsible for initiating revision of Global training plan for the team.

Junior Data Analyst (Quality Control – Pharmacovigilance) at Cognizant Technology Solutions (2012-12 – 2014-10)

• Individual Case Safety Reporting.
• Writing case narratives.
• Working on ARGUS safety database.
• Coding Events and Drugs using Med DRA and WHO-DD.
• Timely submission of cases as per timelines and seriousness of cases.
• Tracking all the Adverse Events reports for medications including Medical devices, Investigational Products, Vaccines, Biologics and OTC products.
• Reviewing and assessing all source documents and maintaining their consistency.
• Performing quality control of cases to authenticate accuracy of adverse event cases and product complaints as per the Standard Operating Procedures and to ensure information reported to Drug Safety Surveillance is complete and accurate within timelines.
• Auditing cases and providing timely feedback for the cases reviewed.
• Submitting timely reports related to case allocation, processing, completion and accuracy of the cases.
• Maintaining Defect Trackers.
• Mentoring new associates.

Clinical Research Associate at Merck Serono Ltd. (2012-06 – 2012-12)

• Post Marketing Surveillance studies.
• Ensuring that study is conducted in accordance with Protocol, Standard Operating Procedures, Good Clinical Practice and Regulatory Requirements.
• Conducting Monitoring Visits in accordance with contracted scope of work and Good Clinical Practice as per ICH-GCP guidelines.
• Administering protocol and related study training to assigned medical care institutions and establishing regular lines of communication with them to manage ongoing project expectations and issues.
• Managing the progress of studies and working closely with Investigators, CRCs & their team to ensure Patient safety.

Research Associate at EDR Continuous Information Pvt. Ltd. (2011-11 – 2012-05)

• Retrieval and analyses of Material Safety Data Sheets (MSDS) of drugs and chemicals.
• Chemical Categorization and Hazard Classification of drugs and chemicals.
• Knowledge and utilization of the regulations and norms of Hazardous Material Identification System (HMIS), OSHA Hazard Communication Standard, National Fire Protection Association (NFPA), Superfund Amendments and Reauthorization Act (SARA): USA, Workplace Hazardous Materials Information System (WHMIS): Canada.

Master's in Business Administration in Business Administration – Jaipur National University (2018)

Post Graduate Diploma in Clinical Research Management – Institute for Clinical Research (ICRI) (2013)

Post Graduate Diploma in Advanced Clinical Research and Pharmacovigilance – Institute for Clinical Research (ICRI) (2012)

Bachelor of Pharmacy in Pharmacy – VES College of Pharmacy, affiliated to the University of Mumbai (2011)