Manjula G
Medical Information Manager
Bangalore
Summary
Seeking senior management roles into Global Medical affairs and Pharmacovigilance in Pharmaceutical and Biotechnology industries; while managing and handling medical services; managed resource planning, inspection, audit, team building & co- ordination with internal & external departments Result-driven professional having 12+ years of experience in Medical Affairs, Medical information and Pharmacovigilance and responsible to manage all the activities in multidisciplinary fields of pharmaceutical industry, operations management, training & development and team management. Proficiency in spearheading Healthcare Management functions involving structuring & implementation of innovative Administrative Policies/ Procedures for the benefit of the organization. Proficient in conducting literature search and compiling medical resource /product scientific data/clinical articles/publications/ studies, and presentations where required. Expertise in providing high scientific Medical information on the company's products to internal and external customers in a manner that promotes the safe and effective utilization of products and the reputation of the company Skilled in effectively managing and communicating large volumes of medical information in an unbiased manner Competent in drug safety surveillance and the pharmacovigilance process concerning compliance with regulatory requirements. Adept at enabling the Medical Affairs Department to be the provider of superior clinical and medical support to all affected departments ensured that all outputs of the department are in line with short, medium and long-term objectives of Drug Management and Development (DMD) and other Healthcare Business Units. Insightful experience in streamlining & implementing patient support programs and Global Safety database. An enterprising leader & a team player with strong abilities in leading motivated teams and coordinating with professionals in different domains to achieve organizational objectives by the use of the industry best practices. Contributed in commercialization of key brands by providing expert scientific knowledge/advice, ensured ethical and credible promotion of brands, managed medical related issues and delivered scientific knowledge tailored to the sales force. Instrumental in setting-up filing system and maintain all Medical information & Pharmacovigilance related documents. Received awards and appreciations, as “star performer” for excellence in medical information customer service. Awarded with 5-year long service award in recognition of excellent service in PV and medical affairs activities while leading all the internal and external medical affairs & PV audits and driving Holistic Risk Assessment initiative in Pharmacovigilance/Safety function.
Overview
13
13
years of professional experience
13
13
years of post-secondary education
4
4
Certifications
Work History
information Manager
Eversana Life, Information
09.2022 - Current
- Science US health care company as Medical, & Communication
- Client Management
- Ensure client success by providing oversight of assigned clients, including implementation,
- Ongoing management, regular touchpoints and meetings
- Understand client needs and ensure deliverables meet expectations, including KPIs and
- Service levels
- Act as liaison with client stakeholders to manage all aspects related to services provided by
- EVERSANA Medical, Contact Center Medical Communications (EVERSANAMICC)
- Perform project escalations in a timely manner when client performance requirements are
- Not met
- Address client concerns in reference to products, services rendered or employee
- Interactions
- Serve as resource person for staff regarding the client, client procedures, and client
- Product(s)
- Participate in client audits and collaborate with EVERSANA Quality to facilitate audits
- Manage client invoicing
- Team Leadership
- Mentor junior staff
- Provide initial and ongoing training to staff
- Ensure staff performance and proficiency across client product(s) & procedures
- Monitor and update client resources to ensure staff has the most accurate and current information
- Maintain client and client product information reference files
- Proactively monitor work processes related to handling medical information inquiries, and assure compliance with client performance requirements of EVERSANA-MICC
- Provide constructive suggestions and follow through with implementation of appropriate changes
- This may include revising/updating content or processes to meet EVERSANAMICC service standards as well as the expectations and requirements of the client(s)
- Medical Information Support
- Triage and respond to medical information inquiries from physicians, pharmacists, nurses, and other health care professionals, consumers, and payers
- Utilize medical information
- Skills to identify, research, and critically evaluate medical literature to create responses to medical information inquiries
- Utilize writing skills for adverse event and product complaint narrative during intake as well as medical inquiry custom responses
- Handle requests across multiple channels and platforms (phone, email, CRM, chat, etc.)
- Identify adverse events and product complaints during interactions with customers
- Perform intake sufficient to generate adverse event and product complaint reports in compliance with EVERSANA-MICC and client standard operating procedures
- Knowledge of FDA’s postmarketing adverse event reporting regulations and safety terminology
- Ability to make accurate assessments regarding what information needs to be obtained and level or depth of information to be collected
- Coordinate processes necessary for responding to product quality-related complaints
- This process may involve interactions with personnel in the following departments: Quality Assurance, Regulatory Affairs, and the complainant
- Maintain product, therapeutic area, and client specific requirements knowledge
- Ensure good documentation, high quality, and excellent customer service
- Medical writing and Medical Information content development
- 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
- Staffing at scientific medical affairs booths
- On-call responsibilities on an as assigned basis
- Miscellaneous projects such as market and competitive product research, operational and process improvements, field team training and field liaison support.
Deputy Manager
Adcock Ingram Health Care Pvt. Ltd
08.2015 - 09.2022
- Looked after Pharmacovigilance services within predefined timelines and sharing the report of Adverse Drug Reactions (ADR's) to regulatory authorities as per regulatory requirements
- Complying with the pharmacovigilance requirements for 3rd party and strategic partner products as per Safety Data Exchange
- Agreements
- Handling quality periodic safety update, annual safety reports & line listings to relevant regulatory authorities
- Conducting scientific Literature Review while performing literature review weekly at the level of the active substance, in accordance with applicable law and guidelines using internationally accepted search engines for safety concerns, drug class effects
- Writing and maintaining SOPs related to drug safety management or including section/text on safety
- Develop and conduct signal detection activities and adverse event trending analysis and prepare signal detection and trending reports
- Assist in the creation, review and implementation of documents and/or tools to align and improve pharmacovigilance processes
- Address client questions on report management and processes, as well as complete client notifications as required for report management
- Managing Individual Case Safety Reports (ICSRs) processing including but not limited to collection, data entry, data QC check, narrative writing, follow up, coding, case closure, case file archiving of SAE/ AE reports from clinical trial and post marketing sources onto the Adcock Ingram drug safety database, in accordance with company SOPs and regulatory requirements
- Preparing Adverse Event (AE) report to strategic alliances on stipulated times in line with safety agreements
- Verifying Analytical tests, ensuring that complaint & retention sample via the Group Quality Assurance (GQA) department customer complaints officer
- Medical Affairs:
- Overseeing daily and overall Medical Affairs, Pharmacovigilance, and Medical Information activities from Technical Service Office
- Managing activities of, reviewing ICSRs, ASRs/ safety updates, regulatory submissions to health authorities, and reviewing safety data exchange agreements with partners
- Monitoring and training team on overall Medical Information and PV operations
- Cooperating with the executive team to initiate procedures, regulations, and programs to benefit our patients and support our health center fiscally
- Creating costing analysis for new procedures and prices increase on existing procedures including benchmarking with available competitor information
- Medical information:
- Providing personalized customer service of the highest level with scientific data within specified timelines
- Acts as a compliance officer for the Medical information & Pharmacovigilance departments
- Respond to customers with desired information by researching Data mining with literature databases such as PubMed, Embase, Ovid, EBSCO, etc
- Provide information support to Sales, Marketing, and Training departments and other business divisions within agreed timelines
- Manage company’s information website and respond to queries logged therein
- Author professional correspondence to Health Authorities, customers, and vendors
- Compile executive monthly, biannual, quarterly, and annual reports using self-developed templates using MS- word, excel, and
- PowerPoint ensuring risks & issues arising are raised timely
- Support librarian in optimizing resources in the information center
- Train & support pharmacists on drug safety matters and medical information
- Acts as a Medical Advisor; train Marketing & Sales team, and conduct CMEs/Patient Support programs; Liaise with Key Opinion Leaders
- Responding to regulatory authority letters on safety/efficacy related issues by providing relevant medical and scientific data
- Medico-marketing, R&D Regulatory Affairs & Continuous Improvement:
- Monitoring and signing off promotional, educational, and marketing aids in accordance with the Code of Marketing Practice
- Developing and fostering excellent relationships with KOLs
- Performing ongoing pharmacovigilance training with measurable improvement in the process and up-to-date with industry standards while guiding new or existing employees
- Completing the project on the schedule based on clinical support for R&D during all the phases of drug development
- Conducting a medical review of regulatory documents like package inserts patient information leaflets, artworks, etc
- Drafting the medical risk assessment for quality complaints.
Clinical Research Coordinator
Poona Diabetic Centre
01.2012 - 01.2015
- Actively involved in data mining, data collections, auditing with sponsors and I am trained in various aspects of clinical research)
Trainee
Chancre Rheumatology & Immunology Centre
01.2011 - 01.2012
- (Undergone practical training in Chancre Rheumatology & Immunology Centre & Research Bangalore)
Education
Post-Graduation Diploma - clinical research, Sysplex Clinical & Bio Solution
Bachelor of Dental Surgery - undefined
Rajiv Gandhi University of Health Sciences
560032 Personal protection Certification from Adcock Ingram Certified medical reviewer for Code of Marketing Practice. Regulatory Affairs Certification from Adcock Ingram Pharmacovigilance compliance certification from Adcock Ingram and Baxter Pharmacovigilance compliance certification from Leo Certified on use of Oracle, Seibel, Argus, Vr safety database in Pharmacovigilance - undefined
TRAININGS & Clinical trial protocol development Clinical trial protocol Development - undefined
University of California, San Francisco University of California, IDA
Post-Graduation Diploma - Medical and scientific writing
High School Diploma -
St Miras English School
Bangalore 01.1987 - 01.2000
Skills
Project oversight
undefinedAccomplishments
1. Personal protection Certification from Adcock Ingram
2. Certified medical reviewer for Code of Marketing Practice.
3. Regulatory Affairs Certification from Adcock Ingram
4. Pharmacovigilance compliance certification from Adcock Ingram and Baxter
5. Pharmacovigilance compliance certification from Leo
6. Certified on use of Oracle, Seibel, Argus, Vr safety database in Pharmacovigilance and medical information operations.
7. TRAININGS & Clinical trial protocol development Clinical trial protocol Development CERTIFICATIONS University of California, San Francisco University of California, San Francisco Issue.
8. The Good clinical practice guidelines The Good clinical practice guidelines Clinical trial network Clinical trial network Issued Jan 2022
9. Attained several Dental Camp conducted by Indian Dental Association (IDA) in the year 2007 as a requirement for course completion.
10. Cleared the Red Cross Society Examination.
11. Attained the temporomandibular joint implants conference held in oxford dental college Bangalore 2009.
·
Certification
Bachelor of Dental Surgery from Rajiv Gandhi University of Health Sciences, Karnataka, India
Timeline
information Manager
Eversana Life, Information
09.2022 - Current
Pursuing Post-Graduation Diploma in aggregate reporting from Cliniminds
03-2022
Post-Graduation Diploma in Medical and scientific writing from Cliniminds ISO 9001:2015 certificated
02-2022
Deputy Manager
Adcock Ingram Health Care Pvt. Ltd
08.2015 - 09.2022
Clinical Research Coordinator
Poona Diabetic Centre
01.2012 - 01.2015
Post-Graduation Diploma in clinical research from Sysplex Clinical & Bio Solution
10-2011
Trainee
Chancre Rheumatology & Immunology Centre
01.2011 - 01.2012
Bachelor of Dental Surgery from Rajiv Gandhi University of Health Sciences, Karnataka, India
10-2008
High School Diploma -
St Miras English School
01.1987 - 01.2000
Post-Graduation Diploma - clinical research, Sysplex Clinical & Bio Solution
Bachelor of Dental Surgery - undefined
Rajiv Gandhi University of Health Sciences
560032 Personal protection Certification from Adcock Ingram Certified medical reviewer for Code of Marketing Practice. Regulatory Affairs Certification from Adcock Ingram Pharmacovigilance compliance certification from Adcock Ingram and Baxter Pharmacovigilance compliance certification from Leo Certified on use of Oracle, Seibel, Argus, Vr safety database in Pharmacovigilance - undefined
TRAININGS & Clinical trial protocol development Clinical trial protocol Development - undefined
University of California, San Francisco University of California, IDA
Post-Graduation Diploma - Medical and scientific writing
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