16 years experience PV and Medical Affairs Professional
Resume:
Career objective
To contribute, succeed as a valuable medical affairs and safety
professional and lead teams, stakeholders through application of interpersonal, analytical, scientific and technical skills gained over the years, and continue to upskill in the healthcare sector, resulting in our mutual benefits and personalising medicine for patients to improve their quality of life.
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Core Competencies
Medical Affairs/Project Management
Real Word Evidence
Medical Writing/Medical Information
Pharmacovigilance
Clinical Trial Safety
Safety Monitoring
Internal and External Stakeholder collaboration
Audits/CAPA/RCA
Vendor Management
People and performance Management
Market research
Benefit Risk Management
Aggregate Reports
IT Systems integration
Budget management
Professional Experience
Novo Nordisk India Private Limited, Bangalore from Apr’25 to Sep’25: Regional Medical Advisor for Odisha, Jharkand, Bihar (Diabetes, Obesity and Cardiometabolic)
Novo Nordisk, Global Business Solution, Bangalore from Sep’23-Mar’25: Associate Manager (Real World Evidence) – Regions and operations (APAC, NWE) and Global Project Manager – International Operations (Obesity, Insulin, MASH,Rare Diseases)
AbbVie Therapeutics/Allergan Aesthetics, Bangalore from Mar’22-Jun’23: Deputy Affiliate Safety Representative/ Senior Manager PV, Medical Affair
Allergan India, Bangalore from Apr’17-Dec’21
Senior Local Safety Officer
ICON plc, Chennai from Apr’16-Apr’17
Trial Master File Lead
Quintiles (IQVIA), Bangalore from Jun’09– Nov’15 Pharmacovigilance Team Lead
Kaliyappa Hospital, Chennai from Dec’08-Jun’09
Assistant Dental Surgeon
Bangalore Diabetes Hospital, Bangalore from Mar’08- Sep’08: CRC - Trainee
Profile Summary
Spearheaded the establishment and maintenance of a robust pharmacovigilance (PV) system and Orchestrated Affiliate safety operations for AbbVie Therapeutics and Allergan Aesthetics for India Affiliate, encompassing territories Sri Lanka, Bangladesh, Nepal with local regulations and company policies since 2017 to 2023
Pioneered the development and implementation of NPSMF, local controlled procedural documents (SOPs, WIs) for efficient PV processes and established quality management systems, conducted self-audits, vendor Audits including systems, database, legislative and GCP, GVP standards
Lead product qualification process of a local tracking database, effectively replacing manual intake procedures & the implementation resulted in the global adoption of the database across all affiliates
Extensive vendor and contract management experience
(Distributors, manufacturers, CROs, IT service providers, HCP and HCO contracts, agreements, Vendor quality assessment, REP, TPR and GDPR)
Composed the monitoring and management of domestic Adverse Drug Reactions (ADRs)/Adverse Events (AEs), guaranteeing a safe environment for locally marketed products and clinical products
Ensured compliance with GCP, GVP, US-FDA, EU MDR and corporate PV procedures, identified and managed non- conformities and departures, and implemented
corrective/preventive actions to maintain high compliance standards before and after PV Audits.
Planned, implemented, and monitored the PV training plan, ensuring compliance
Review of protocols, investigator brochure, informed consent, and safety management plans of clinical trials
Played a pivotal role as an active stakeholder in Launch Excellence matrix teams, contributing to successful product/indication launches & local safety planning initiatives.
Liaised directly and indirectly with regulatory bodies on a regular and ad hoc basis, providing advocacy to ensure compliance with regulatory requirements
Directed regulatory intelligence efforts to stay abreast of evolving industry guidelines and ensure compliance
Streamlined scheduling, authoring, reviewing, and timely submission of PSURs, signals, and RMPs, ensuring regulatory compliance
Fostered strong partnerships with distributors, manufacturers, business partners, and third-party representative, and managed by skillfully implementing quality management systems to secure reliable and proficient third-party representatives
Spearheaded the review and compliance monitoring of market research studies, patient assistance programs, and data collection initiatives
People leader for a team of 11 RWE project management professional who runs RWE studies and Performance
management personnel & Strategize for the team development and contributed in Organization development Plans
Strategic partner to Medical Directors, for medical portfolio projects Provide expert medical advice for products and related therapeutic areas, including responding to requests for scientific information from HCPs
Pre, Peri and Post launch activites of Wegovy (Semaglutide 2.4), Post marketting management of Novo Nordisk Insulin Range and oral semaglutides in the assinged territory (Odisha, Jharkand and Bihar)
Participated in KOL, HCP engagement and collected insights to action
Provide input to the development of materials for medical and scientific accuracy generated by the HO medical.
Execute HO strategical activities in the assigned regions, design and deploy regional medical activities working alongside with frontline excellence team.
Dr. RAJASUNDAR THIYAGARAJAN
B.D.S., PGDCTM
Strength
Dental surgeon aspiring to add more value through contributing more to medicine through passion and
transferable skills gained over the years
Multi Therapeutic area expertise (Hepatology, Obesity, Cardiometabolic, Rare diseases, Ophthalmology and
Neurology)
Collaborated with large numbers of HCPs/KOL/DOL, non- HCP (IT, Finance, Admin, etc internal and external stakeholders and possess a practical working knowledge on day today basis
Demonstrated as a subject matter expert, operational, strategic and people leader in matrix environment
Influenced and aided in formulation and execution of short-
, mid- and long-term strategies, in a life cycle of a product, TA and cross functional collaborations
Strong business acumen, ability for crisis management through critical thinking
Soft Skills
Membership
Member of Dental Council of India (Tamil Nadu Reg. No: 10330) Certifications
Member of Association of Clinical Research Professionals
(ACRP), 2010
Certified in Project Management Basic Course from LinkedIn in 2021
Completed the “Six Sigma” course from Udemy in 2021 Therpay Area experience
Obesity
Cardiometabolic
Rare Diseases (Growth hormones, RBD)
Diabetes
Insulin
Eyecare
Neurology
Dentistry
Personal Details
Date of Birth: 24th March 1984
Languages Known: English & Tamil (Fluent)
Address: Bangalore, India
Education
Post-Graduation Diploma in Clinical Trial Management (ACRP-CKA 89%) from Bilcare Research Academy, Bangalore in 2008
Bachelor of Dental Surgery (BDS) (First class) from Tamil Nadu Govt. Dental College & Hospital, Chennai in 2007
Technical Skills
IO ENGAGE
COUPA
PeopleStorng and HR tools
ODP
Teams channel
MS Sharpoint
eTMF (Wingspan)
Medidata Rave
Argus LAM
Clintrace
InForm
MS Access
Argus
CTMS
MedDRA
ARISg
Trilogy
Veeva Vault Safety
Oracle Empirica
PowerPoint
Visio
Lassie
Brainshark
TIBCO Spotfire
Agreement (SDEAs. PVAs, HCP and Agency)
Clinical Trial Documents
Current Work Experience
Novo Nordisk India Private Limited: Apr 2025 – Sep 2025 Regional Medical Advisor – CMR – India
Provide expert medical/scientific advice for diabetes, Obesity and GLP1 TA including responding to requests for scientific/technical information; contribute to the development and medical and scientific material generated by the medical department
Pre, Peri and Post lauch activites of Wegovy, Post marketting management of Novo Nordisk Insulin Range in the assinged territory (Odisha, Jharkand and Bihar)
Engaged with KOLs and HCPs on scientific discussions during conferences and third party meetings.
Delivering medcial information through OCE/MCE
Budget and resource management in compliance with ethics and compliance on FMV, Contracts and compensations relating to country regulations and organization standard
Design and deliver comprehensive training programs for the sales team members
Conducting and moderating CMEs and brief HCPs for dissemination of accurate scientific and safety information.
Review and preparation of scientific material to Ensure the medical/scientific content is correct and fully compliant with internal policies and guidelines
Established and maintained professional and credible relationships with key opinion leader by participating in scientific congresses, cohort meetings, coordinating advisory board and deliver presentations and medical education programs to healthcare professionals individually as well in groups.
Medical/scientific input into marketing and Sales strategy and key commercial initiatives, as required in the region during and after Launch
Effective
communication
Interpersonal
skills
Adaptable
Emotional
intelligence
Analytical
Active
listening
Problem
solving
Roles Across the Career (Safety)
Maintained a high level of PV compliance by actively monitoring the affiliate's PV system, proactively identifying and recording noncompliance and potential PV resource issues, and taking appropriate actions
Streamlined workflow to monitor post-marketing and clinical PV legislation changes, facilitating effective communication & compliance adherence to NRA
requirements
Planned, implemented, and monitored the PV training plan, ensuring compliance of local PV personnel and other affiliate personnel with corporate and local PV training requirements
Developed and implemented local controlled procedural documents (SOPs, WIs) for applicable PV processes in collaboration with functional heads
Safety Project Management of Startup, maintain, closure of standalone PV projects and PV aspect of full scope projects from Clinical trial (full scope and post box) (Phase 1,2,3), Spontaneous (full scope and post box), Other solicited studies, Literature search, review and processing, Vaccine studies, Medical Device studies and Database migration.
Monitored domestic Adverse Drug Reactions
(ADRs)/Adverse Events (AEs) and maintained a compliant PV system in the assigned countries
Provided input on local risk management activities and participated in the scheduling, review, and regulatory submissions of PSURs, signals, and RMPs
Provided functional oversight of distributors,
manufacturers, business partners, and third-party vendors within the PV scope, ensuring compliance with PV standards and requirements
Orchestrated accountability for the India PV System while taking full ownership of affiliate PV Systems
Spearheaded the product qualification process of a cutting- edge local tracking database, effectively replacing manual intake procedures & the implementation resulted in the global adoption of the database across all affiliates
Acted as the main point of contact during local audits, managed and documented audit and inspection
communications, and facilitated audit finding remediation.
Effectively managed resources and multiple projects to ensure timely submission of reports to the global case processing team, assigning daily work based on priorities and requirements
Participated in CRF review meetings with data management, both internally and externally
Conducted product qualification, extensive User Acceptance Testing (UAT) for databases, customizing specifications for each protocol and product (Argus, Clintrace, Apex)
Liaised with various team members, including project management, clinical, and data management, to address project-related challenges.
Reviewed CRFs and CIOMS forms to identify and reconcile AE and SAE data for Clinical Safety Reports
Engaged in review of Labeling, SMPC update in collaboration with regulatory department
Supported study teams in addressing and reporting regulatory queries related to document management
Review of protocols, investigator brochure, informed consent, and safety management plans
Led the setup of TMF Study Specific Document Lists (SSDLs) and monitored the completeness and quality of TMF content until study closeout
Provided education, feedback, and support to study teams on document management practices and TMF for clinical trials
Owned complete and accurate Trial Master Files (TMFs) for assigned clinical trials, ensuring consistency with specifications, SOPs, guidelines, and regulatory
requirements
Roles Across the Career (Medical Affairs)
Performed as strategic partner to the Medical Director, in the planning and delivery of medical affairs projects (Including but not limited to KOL engagement, Toolkits for best practices, Preceptorship, AdBoards, Ex committee, Real World Evidence studies, Abstracts, Posters, Manuscripts and Publications)
Experienced in execution of Disease area studies, Non interventional studies) and secondary RWE studies (data base and registries), market research and social media listening) as program manager and people manager
Formulate, Plan, Execute, monitor and Close out of RWE projects from every region and affiliates on therapeutic areas of obesity, diabetes and rare diseases (SCD and Hemophilia)
Collaborate with stakeholders (medical managers, RWE directors/ managers, Epidemiologists, biostats, medical writing, Data management, Safety, Publication team and site CRAs for Study design, EDC set up, statistical analysis plan, monitoring, develop NSR, readouts of study results and publication)
Formulation and execution of projects within timeline and budgets and follow good documentation practice for audit readiness.
Formulated Real World Evidence strategy to elevate overall business performance in collaboration with Medical and scientific advisors, HEOR, Payer evidence BU to ideate patient-centricity projects (Ex. Social media surveillance)
Exercised astute critical thinking to drive strategic operations and enhance overall business performance in collaboration with regions and operations Value chain for a global RWE program that has series of activities from every value chain for a major RWE program that span over upcoming years.
Strategize for the team development and contributed in Organization development Plans
Conducted workshops and Lead the roles and responsibility/ core competency mapping project for RWE academy in regions and affiliates of international operations
Initiated, planned, executed, monitored, and closed various business unit initiatives
Led the process of safety inputs in designing, monitoring of multiple Patient Support Programs, Market research initiatives, Patient Registries, Disease awareness programs, social media, and PR initiatives (non-promotional) in collaboration with commercial, regulatory affairs and product management teams.
Led the review and assessment of questionnaires for HCPs, patients, and focus groups to gain insights into disease and treatment trends during non-promotional events and data collection programs
Led the review and assessment of questionnaires for HCPs, patients, and focus groups to gain insights into disease and treatment trends during non-promotional events and data collection programs
Handle MI requests across multiple channels and platforms
(phone, email, CRM, chat, etc.)
Identify adverse events and product complaints during interactions with customers
Provide medical writing to assist in drafting of Medical Information response documents [FAQs, Scientific Response Documents (SRDs), Custom Response Documents (CRDs)] and/or work collaboratively with medical writing team to develop these materials
Set goals and performance management of team and individuals
Submitted reportable Individual Case Safety Reports (ICSRs) to regulatory authorities and distributor MAH in compliance with national PV legislation.
Collaborated with the global training manager to plan and deliver training for new hires, annual training for local employees, and third-party vendors
Directed regulatory intelligence efforts to stay abreast of evolving industry guidelines and ensure compliance
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