Hi, I’m
ANKITA MUKHERJEE
Medical Review Manager
Ulwe
Summary
Energetic and results-driven professional with expertise in process improvement, problem-solving and fostering a culture of accountability and excellence. Well-versed in team collaboration, operational efficiency, and achieving measurable outcomes along with strong analytical and communication skills. Known for adaptability and consistently meeting changing organizational needs.
Committed to driving team success and achieving organizational goals.
Overview
14
years of professional experience
11
years of post-secondary education
Work History
Pfizer Products India Pvt Ltd
Medical Review Manager
02.2020 - Current
Job overview
- Performs medical pre-review (reference check) of promotional, sales training and medical to medical materials including but not limited to Health Care Professional (HCP) promotional aids, Web/Social, training material, advertisements, consumer promotions, conventions/meetings etc to ensure:
- The claims are accurate, truthful, not misleading and aligned with Core Claims, Common Technical and/or other regulatory documents
- The references are adequate, and they fully support the relevant claims
- The claims are consistent with the specified reference label used
- Providing support to the Global Medical Affairs group including but not limited to ad-hoc literature searches, reviews and summaries, preparation of slide decks
- Researching literature databases, internal and external repositories to support the evaluation of Health Hazard Assessments and the benefit-risk of Pfizer products
- Support for major regulatory agency submissions, Clinical Overviews, Health Hazard Assessments, listings and summarizing the results of the above research to the required standard if needed by the stakeholders
- Supervision and review of promotional, sales training and medical to medical materials work performed by the associates in order to provide high quality and timely service
- Ensuring delivery of all required activities within expected timelines
- Support for scientific congresses through review of content and congress reports
- Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams in a timely manner of any definite or potential deviations
- Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents
- Deliver assigned documents on or before deadline, alerting project teams in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality
- Collaborate with other lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents
- Creating documents pertaining to clinical data, company data, published literature and other data to support the maintenance and defense of our products
- Providing expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents
- Assessing document requirements, gauging document complexity, and identifying information gaps or other potential issues
- In collaboration with the relevant GMPE TA Lead, the author proposes or contributes to strategies to resolve any identified issues
- Clinical and scientific medical writing, editing, and quality control review (QC) for regulatory documents including clinical study reports, safety narratives, protocols, protocol amendments, investigator brochures and submission documents
- Manuscript writing including researching, organizing, compiling, interpreting and quality checking various types of technical and/or medical information
- Creating Process Guidance Document as part of Audit Remediation
- Training, Onboarding & Mentoring of New team members
- Collation, verification & analysis of data pertaining to different activities involving MRE & stakeholders
- Training of Agencies regarding document upload for review
- Conducting interviews to fill up vacant positions within the team
- Quality checking for the single reviewed pieces as well as Process Guidance Document related documentation
- Participating in a few Pilot projects to enhance the overall quality of the existing process and expansion of MRE e.g
- Copyright Permission Project
- MLR Quality Oversight Pilot
- Revamp of analytical tools
- Stakeholder mapping analysis to find out the areas of work
- Participating in Stakeholder meeting / MRE expansion activities
- Complete management of Metrics Harmonization Project as the Project Lead
Raptakos, Brett & Co. Ltd.
Manager - Nutrition
05.2019 - 02.2020
Job overview
- Providing medical expertise support for further development & improvement of existing vast array of nutraceuticals
- Researching & developing new communication from Medical perspective
- Medico-marketing activities Ensuring accuracy, credibility & consistency of key marketing messages & activities
- Editing and reviewing patient education modules, LBLs, Audio Visuals
- Helping in brand related communication
- Creating nutrition profile of new products
- Claims substantiation
- Reviewing scientific literatures
- Content development & review for the website
- Smooth functioning of the website
- Creating, editing & reviewing posts and content published on Digital Platform
- Training of the sales force regarding Brand Science
Danone India
Nutritionist in Healthcare Nutrition Science Team (Medical Affairs)
05.2013 - 05.2019
Job overview
- Providing medical expertise for further development & improvement of existing products
- Researching & developing new communication from Medical perspective
- Medico-marketing activities
- Ensuring accuracy, credibility & global consistency of global marketing messages & activities
- Attending to consumer enquiries on Nutrition & Health issues
- Editing and reviewing patient education modules, LBLs, Audio Visuals
- Helping in brand related communication
- Being responsible for creating the nutrition profile
- Claims substantiation
- Reviewing scientific literatures
- Content development & review for the website
- Smooth functioning of the website
- Planning & execution of Workshop, CMEs in collaboration with Marketing Team
- Developing and conducting nutrition seminars for health professionals and public on relevant product related issues
- Organizing Webinars with KOLs
- Establishing and maintaining networks with local regulators, government departments, key opinion leaders and organizations
- Creating, editing & reviewing posts and content published on Digital Platform
- Training of the sales force regarding Brand Science
- Conducting training sessions for the internal employees on their holistic health & wellbeing
- Conducting training workshops on First 1000 Days
- Handling consumers of Danone Dairy products, ELN (Early Life Nutrition) products & Protinex portfolio
- Customer Interactions- providing information, arranging for required products
- Coordinating with field force across India & maintaining protocol of quality control (arranging for investigation of the products against complaints)
- Taking consumers' complaints, analyze for resolution
- Bridging between product manufacturing unit & HO regarding consumer interaction
- Closure of complaints with cooperation of quality team
- Organizing sensory tests for creating sensory panel
- Preparing presentations regarding marketing material
- Assisting marketing team regarding literatures
- Preparing paint balls
- Comparative analysis of various products
- Taking care of the content of a Facebook page and interacting with the followers
Bhagirathi Neotia Woman & Child Care Centre
Administrative Nutritionist
12.2008 - 09.2009
Job overview
- Company Overview: super-speciality
- Maintaining day to day admin
- Records of the food department - reporting to GM Admin
- Maintaining/supervising the inflow-outflow of food material/raw material - generating QA compliance report
- Interacting with the patients regarding their diet
- Counselling patients in in-house Bone& Knee Joint clinic - providing Diet Consultation
- Instructing cooks regarding the preparation of the foods as per patients' requirements
- Supervising stewards for supreme quality service to patients' rooms
- Arranging training programmes for cooks and stewards - Food required for Pregnant, Lactating women, and also children from 6months - 12 years
- Coordinating with outsourced F&B Manager for best of their services
- Interacting with the doctors regarding complications of the patients
- Answering patients' queries regarding food department
- Handling patients' complaints - SPOC to the patient and their families - overall administration handling - publishing of M.O.M
- To the GM-Admin on daily internal meetings
- Super-speciality
Sanofi-Aventis
Diabetes Patient Counsellor & Nutritionist
04.2007 - 07.2008
Job overview
- Visiting patients regularly
- Counseling the patients regarding diabetes, diet and lifestyle modification
- Teaching them the usage of insulin
- Helping them bringing their blood sugar level under control
- Helping them removing their various misconceptions regarding diabetes, insulin etc
- Answering all of their queries
- Attending camps
- Meeting doctors
- Presentations to the doctors and patients
VIBES
Dietician
02.2007 - 04.2007
Job overview
- Interacting with clients
- Help clients reducing and maintaining their body weight
- Counselling clients regarding their diet and lifestyle modification
- Training and heading slimming department staffs for proper functioning of the department
Education
GMDP Academy & King's College, LondonLondon
Certification in Medicine Development from Medical Affairs in Medicines Development
01.2023 - 01.2024
Symbiosis Centre of Health CarePune, Maharashtra
Post Graduate Diploma in Hospital & Healthcare Management
06.2008 - 05.2009
University Overview
- 1st DIVISION
- GPA: 61.0%
Calcutta University
M.Sc. from Food & Nutrition
07.2004 - 11.2006
University Overview
- 1st CLASS
- GPA: 68.80%
Calcutta University
B.Sc. from Food & Nutrition
07.2001 - 04.2004
University Overview
- 1st CLASS
- GPA: 68.75%
Beltala Girls' High School
Higher Secondary (+2)
07.1999 - 06.2001
University Overview
- 1ST DIVISION
- GPA: 70.0%
United Missionary Girls' High School
Madhyamik Exam (10th)
05.1997 - 05.1999
University Overview
- 1ST DIVISION
- GPA: 81.25%
Skills
ENGLISH - Fluent
Accomplishments
- Gold medalist in National Inter School Table Tennis Championship (1996)
- 2nd position in Oral Paper Competition (National Seminar, 2006)
- Participated in International Congress on Cardiovascular Diseases (2006)
- Awarded Best Upcoming Talent in Aventis (2007)
- Received Pfizer BRAVO recognition across all 4 Pfizer values from Stakeholders, peers and Leadership
- End of Program Assessment (EPA) essay submitted during the GMDP Academy – King’s College London course on Medical Affairs in Medicine Development in end of 2023, has been recognized as one of the highest-scoring submissions and GMDP Academy has published it in their September 13 2024 edition newsletter
Current Industry
Healthcare / Pharmaceutical / Food
Personal Information
- Maiden Name: ANKITA SAHA
- Father's Name: HARI BHAKTA SAHA
- Date of Birth: 05/30/83
- Marital Status: MARRIED
Currentlocation
Casablanca, Flat - B203, Plot - 321, Sector - 19, Ulwe, Maharashtra, 410206
Timeline
GMDP Academy & King's College, London
Certification in Medicine Development from Medical Affairs in Medicines Development
01.2023 - 01.2024
Medical Review Manager
Pfizer Products India Pvt Ltd
02.2020 - Current
Manager - Nutrition
Raptakos, Brett & Co. Ltd.
05.2019 - 02.2020
Nutritionist in Healthcare Nutrition Science Team (Medical Affairs)
Danone India
05.2013 - 05.2019
Administrative Nutritionist
Bhagirathi Neotia Woman & Child Care Centre
12.2008 - 09.2009
Symbiosis Centre of Health Care
Post Graduate Diploma in Hospital & Healthcare Management
06.2008 - 05.2009
Diabetes Patient Counsellor & Nutritionist
Sanofi-Aventis
04.2007 - 07.2008
Dietician
VIBES
02.2007 - 04.2007
Calcutta University
M.Sc. from Food & Nutrition
07.2004 - 11.2006
Calcutta University
B.Sc. from Food & Nutrition
07.2001 - 04.2004
Beltala Girls' High School
Higher Secondary (+2)
07.1999 - 06.2001
United Missionary Girls' High School
Madhyamik Exam (10th)
05.1997 - 05.1999
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