Manish Dattani

• Provides expertise & leadership in pre and post marketing risk management for investigational and marketed products supporting global, regional, and local teams, aiming at patient safety.
• Develops the global risk management strategies to optimize the benefit-risk profile, for initial submissions or marketed products in coordination with relevant functions (e.g. pharmacovigilance, epidemiology, medical, regulator, marketing/commercial) interacting with regulators or external experts.
• Obtains endorsement from appropriate senior committee(s)
• Ensures development of RMP document (regulatory document of submission dossier) leading a cross-functional team (eg, RMP task force satellite of the product submission task force)
• Supervises globally the appropriate implementation of risk minimization activities beyond routine for concerned products, using a validated electronic tracking system to monitor the local implementation data in collaboration with a cross functional team (regulatory, medical, pharmacovigilance and marketing/commercial)
• Participates to (senior) management committees as needed.
• Manages external interfaces with partners for investigational products and/or marketed products.
• Participates as subject expert matter (SME) for risk management process to inspections/ audits.
• Acts as primary contact for the RMP Team on specific topics (e.g., SDEA).
• Delivers RMP trainings to internal and/or external audience.

Training and Mentoring:

• Providing group training for the technical topics
• Providing individual training to under performer
• Training and mentoring to new joiners.
• Identify area of improvement from feedback (external / internal) and quality review comment
• Periodic connect with PVS Manager, Line Manager and GBU Lead (PVS) on quality discussion.
• Communicate change in process at client level and arrange session, if required
• Communicate new regulatory changes which will impact day to day activities of PVSs.
• Support individual for critical report/issues (e.g. HA Query response, Response to PBRER AR etc.)
• Preparing individuals for QCer role.

Quality oversight

• Developing quality system and quality monitoring mechanism
• Screening of QC checklists for ongoing assignments, monitoring QC score
• Based on quality, identifying out performer and under performer, which support for performance review
• Monitor internal / external stakeholders’ comment and take appropriate actions, wherever applicable
• Review compliance check.
• Support manager to prepare quality oversight report.
• Support to develop and maintain quality measuring infrastructure (QC checklist database, Quality dashboard)
• Develop/support development of feedback mechanism for PVS from internal and external stakeholders.

Leadership

• Provide quality input to individual.
• Provide quality related data / report to management.
• Form a framework of performance monitoring of PVS with support of the feedback survey, managers, and leadership.

• Managing signal detection activities - Core member of the Safety Management Team, including setting agenda, producing necessary data outputs, requesting contribution of all functions, preparing slide presentations, facilitating discussions & documenting conclusions
• Coordinates and authors responses to regulatory agencies or responses to inquiries from internal or external stakeholders
• Act as subject matter expert, conduct reviews, provide input and feedback in the areas of aggregate reporting, signal management and benefit-risk management.
• Preparation and review of aggregate reports’ relevant safety sections to ensure consistency across documents and support response preparation in support with GSO for benefit risk sections.
• Team management – Managing team of 10 members.

• Analyze data, author and review complex aggregate and benefit risk management reports of safety data.
• Contribute knowledge and expertise to assigned deliverables in the field of Safety Aggregate Reporting and Analytics (SARA) and Benefit Risk Management (BRM).
• Act as mentor to junior members of staff.
• Serve as principal owner of SARA and BRM deliverables, responsible for completion of the document in compliance with all applicable regulatory requirements and customer service level agreements.
• Attend internal and customer project team meetings (face-to-face, online or via teleconference) as defined in the scope of work (SOW) and budget. May also serve as the Program Lead (where there are multiple SARA projects within the same programs) or the customer representative/relationship manager (if identified). Address all review comments by both internal and external stakeholders.
• Chair planning meetings, data interpretation meetings, online documents review meetings, as required.
• Ensure that a positive, collaborative team environment with SARA team members is maintained, encourage, motivate, and lead by example, provide training and mentoring for team members, Safety Operations and BRM staff, as appropriate.
• Collaborate with managers to resolve performance related; staff efficiency; morale issues within teams.
• Ensure compliance to IQVIA high quality standards and works with LSM, Medical and BRM constructively in a matrix framework to achieve project and customer deliverables.
• Work closely with case processing service operations to resolve issues, if any.
• Interface with other functional groups, such as Regulatory Affairs, Clinical/Medical Affairs functions, Quality, Information Technology, or other business units as needed.
• Drive continuous process improvements.
• Implement and support service operational decisions as determined and instructed by senior management.

• Quality Review of Risk Management Plan (RMP) (For Generic products, Biosimilars and NCEs).
• Quality check of aggregate reports (including PSURs, PBRER, PADERs, DSUR, ACOS etc.).
• Responding to regulatory assessment report on PSUR, RMP etc.
• Supporting to aggregate reports schedule preparation and maintenance.
• Complying with regulatory submission requirements.
• Handling regulatory authority queries on aggregate reports.
• Facing regulatory authority inspections and client audits.
• Prepare and update SOPs and Work Instructions as per current guidelines.
• Training team members.
• Supporting for team management.

• Management of the SAE reports from a medical, regulatory, and administrative standpoint.
• Development of Pharmacovigilance Master File (PVMF) as per EU Regulation.
• Preparation of PADER and PSUR.
• Molecule specific global literature search.
• Provide oversight and supervision of periodic literature searches regarding AEs reported in the local and foreign literature.
• MedDRA coding.
• Preparation of event narratives.
• Review of the SAEs for administrative and medical consistency; including requesting follow up and clarification information from the investigator.
• Submission of SAE reports to the relevant local operating unit.
• Contribute to the training of the members of a study team (including CRA, study coordinators) involved in the clinical research as far as Safety and Pharmacovigilance are concerned.
• Contribute to the Writing of SOPs.
• Submitting expedited reports and individual case safety reports.
• Preparation of summary tabulation.
• Provide support to investigator for preparation and updation of Investigator Brochure, Package Insert and/or SPC, Risk Evaluation and Mitigation Strategy (REMS).
• Responding to queries regarding the safety profile of marketed products.

• Preparation of protocol and CRF of Pharmacovigilance Study.
• Conducting of Phase IV clinical Trial.
• Designing of Pharmacovigilance SOPs.
• Preparation and submission of PSUR for marketed products in different territories.
• Follow up for reported ADRs.
• Response summary preparation for reported ADRs.
• Updating of safety profile for marketed product.
• Updating of Company Core Safety Information and Prescribing Information.
• Maintaining of ADRs database.
• Handle medical query.
• Preparation of Protocol, CRF and report of Clinical Trials and BA/BE Study.
• Monitoring of clinical study.