Santosh Suryawanshi

• Lead development of both short-term and long-term Aggregate report group strategies to assure compliance and client satisfaction for investigational and marketed products
• Subject Matter Expert in all kinds of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities
• Subject Matter expert in handling regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries
• Predicts project pipeline, resource requirements, and recruitment needs and strategies in collaboration with head of DSS
• Provided leadership to global aggregate reporting team including training, mentoring and development of processes compliant with current regulations
• Leads business development initiatives by providing operational input into proposals and scope of work
• Assisted senior leadership in managing all aspects of operations.
• Trained and developed department leaders and management staff for specific projects and ongoing operational needs

• Account and delivery: management
• Overall Project Management, Team Management and Client coordination
• Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
• Ensure delivery of services meets or exceeds Service Level Agreements through focused metrics management of process performance
• Accountable for managing delivery of service for the assigned engagement(s) as per the defined process and SLA
• Responsible for profitability and other key service delivery related metrics
• Solution
• Provide guidance and support to the team of Associates, TM and PMs for proactive solution to the business issues
• Support responding to RFPs as required
• Implement transition plan for new process engagements to establish delivery of service by Labcorp team
• Involved in preparing SOWs and co-ordination with legal team for finalization post successful pursuit
• Support sales group during first pitch, client visit, due diligence and advisory meetings
• Support the solution development team and proactively engage with experts across LabCorp to create bespoke regulatory solutions that maximize value for the customer and differentiate Labcorp from its competitors
• Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
• Consolidated vendors and renegotiated contracts to optimize costs.
• Executed appropriate staffing and budgetary plans to align with business forecasts.

• Domain Lead-Pharmacovigilance, Product safety surveillance and Risk Management
• To support and manage functional areas of the Aggregate report writing team (writing, records management, budget, training and mentoring and QC)
• Plan and oversees the daily activities of aggregate report writing project
• Overall accountability for delivery on Service Level Agreements
• Provide mentoring and development of staff to take on additional responsibilities and advance in their career path
• Prepare and manage project budgets and resource models
• Governance, develop and oversee the training plans for department
• Support the tactical execution and detail deliverables to support global regulatory requirements
• Subject Matter Expert on creating a global PV standardization/harmonization Framework in organization
• Supporting business development team to create effective model on pharma business solutions for EU and US market
• Respond and design solutions to RFPs, creating business plans, mainly create a platform to develop Pharma domain at TCS
• Establishing complete and full-scale Pharmacovigilance operations, Business Development (RFIs, RFPs, Bid defense, Due-Diligence, Strategic and Transition planning), Training, Project Management, Expertise in Drug

• Handled the team of aggregate report writing for day-to-day activities
• PSUR Writing with information from various literatures, clinical trial, regulatory and safety information, etc
• Managing proper distribution of work by delegating the PSURs received according to the availability of resources
• Preparation of Renewal PSURs, PADERs, Addendum Reports and Reviews
• Arranging brain-storming sessions with the team on a regular basis to discuss about the feedbacks, process improvements, PSUR template update, variation in regulatory guidelines, etc
• Use of Quality Tools like CAPA, RCA, Pareto Charts and Green Star to achieve higher Quality scores and increased client satisfaction
• To train new candidates with respect to ICH Guidelines, EMEA, PSUR Writing, SOPs and WI, etc.

• Wrote regulatory PSUR, PADER, Annual safety report and SMR report for Epilepsy and Parkinson's disease
• Collected line listing information, wrote summary narrative and sent it for final review for medical reviewer
• Reviewed all forms and documents pertaining to a case for errors, missing information and legibility
• Performed quality review of the all the safety reviewer, triage and case processing team member
• Prepared monthly quality analysis report and sent it to the client
• Prepared error trend analysis report
• Discuss the issues regarding case processing with Client and seek clarification on the same
• ICSR case processing of all post marketing and clinical trial reports
• Submission of cases to FDA & helping the Medical Writing team with proper case alignment for PADER submissions

• SAE receipt: receive serious adverse event report by email or fax, reports received from global sources
• Case initiation: identify duplicate cases, enter basic data into database, create tracking number and acknowledgereceipt of case to sender
• Triaging of all serious, non-serious and literature cases
• Scientific Assessment: Assess appropriate labeling documents for client products, create company opinion ofcausality
• Performing single case assessment of the medical report based on medical judgment
• Letter/Report writing and sending write and send letters and reports, close report on database
• Narrative Writing: Write narrative for all clinical and non- clinical medical reports based on medical judgment
• Assess Serious Adverse Event / Post Marketing Adverse Event for seriousness, causality and expectedness as perthe Investigator Brochure/Basic Prescribing Information/US package insert, consulting the medical safetyphysicians
• QR (Quality Reviewing): Assess the quality of the associate in terms of narrative writing, case processing, data-entry, find the error rate individual associate and prepare quality metrics for each associate
• Preparation of SOPs & Working practices for Pharmacovigilance-related processes
• Responsible for managing the Reports of Adverse Events, and providing assistance and support for FDA, EMEA,and MHRA'S post marketing safety surveillance

Diploma in Pharmacy