Contact Details Safety
Resume:
Kalindi Hapani
Drug Safety Risk Management & Aggregate Professional
Drug Safety professional with over 12 years of experience in Pharma world and 6+ years dedicatedly in the field of Pharmacovigilance.
Recognized for ability to efficiently managing different projects single-handedly with satisfactory results and achieved excellent feedback from clients.
Poster presentation in ICPE ALL Access 2020, held by International society of pharmacoepidemiology, on “Monoclonal Antibody induced Progressive multifocal leukoencephalopathy and Cytokine release syndrome: Analysis of EudraVigilance and FAERS databases and Risk minimisation measures”.
Speaker presentation in DIA 2019 at San Diego, USA on “Analysis of Biosimilars approved in EU and US: Insights into Risk Minimization Strategies”
Poster presentation in DIA Europe 2018, held in Basel, Switzerland on “Educational material, the most common tool for risk minimisation: analysis of published European Public Assessment Reports”.
Risk Management Plans
Preparation & Review of Global RMPs (including EU and REMS), Developmental RMP (DRMP), Core RMP etc
Risk minimisation measures implementation and tracking including training and organising workshops for stakeholders for approved additional risk minimisation measures (ARMMs)
Preparation & review of Effectiveness assessment reports for ARMMs, periodic review of RMPs etc.
Aggregate Reports
Preparation & Review of PSURs/PBRERs, PADERs, DSURs etc.
Other Safety Documents
Preparation of Integrated summary of Safety & Efficacy, HCP & Patient Educational materials, Post-marketing surveillance protocols
Employee Training related documents
Preparation of Standard operating procedures, work instructions, training modules e.g. authoring of RMPs etc.
Application of Implementation Science Best Practices in the field of dissemination and Implementation.
Development of Patient engagement strategies for successful RMM implementation
Experience in different therapeutic areas with the emphasis on oncology (biologicals and biosimilars), Renal disorders, Anti-infectives etc.
ASSISTANT MANAGER, APCER LIFESCIENCES, GUJARAT, INDIA
(APRIL 2018 To CURRENT)
Responsibilities:
Providing contribution to global Risk Management plans, Aggregate reports and other safety documents
Risk minimisation measure tracking along with the engagement with local affiliates and training requirements on RMMs
Ensuring the overall quality and compliance of safety documents prepared by team
People management- training & Development of employees
Handling client queries, maintaining a good relationship with customers, and organizing meetings and conferences
Achievements:
‘Best team’ award received from the company for 100% compliance and sharing high quality documents to clients
Provision of excellent work in the existing project led client to award with new project
TEAM LEAD, APCER LIFESCIENCES, GUJARAT, INDIA
(APRIL 2017 TO MARCH 2018)
Responsibilities:
Allocation of work/reports to the team.
Ensuring the quality and compliance of the documents prepared by the team
Development of Work Instructions, SOPs and RMP templates
Achievements:
Award received for ‘Excellent Process’ from the company for maintaining the flawless process with no major or critical findings during inspection or audit held in last 2 years
Received ‘Certificate of Recognition’ for being an excellent, mature and dependable leader’ from APCER Life Sciences in the year 2017.
SENIOR PHARMACOVIGILANCE ASSOCIATE, APCER LIFESCIENCES, GUJARAT, INDIA
(NOVEMBER 2015 TO MARCH 2017)
Responsibilities:
Review and compilation of Risk management plans, Pharmacovigilance plan and Risk evaluation mitigation strategy as per the Europe and US FDA guidelines.
Maintain awareness of changes to/new regulations affecting pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes.
PHARMACOVIGILANCE ASSOCIATE, APCER LIFESCIENCES, GUJARAT, INDIA
(MAY 2014 TO OCTOBER 2015)
Responsibilities:
Authoring of risk management and pharmacovigilance plans.
Provide technical and scientific support to the Drug Safety Physicians in all activities related to risk management planning, including review and analysis of safety data reports arising from post marketing surveillance data and clinical trials.
Achievements:
Awarded with ‘Certificate of Appreciation’ for successfully prioritizing work and achieving the expected outcome from APCER Pharma (Europe) Ltd. In the year 2014
LECTURER, SMT. R. D. GARDI COLLEGE OF B. PHARMACY COLLEGE, GUJARAT, INDIA
(MARCH 2009 TO JANUARY 2012)
Teaching and supervision of B. Pharm students
Contribution to the development, planning and implementation of a high quality curriculum.
Assist in the development of learning materials, and maintaining records to monitor student progress, achievement and attendance.
Participation in the marking of exams and other assessments.
PHARMACIST, DHARTI MEDICAL STORES, GUJARAT, INDIA.
(2003 TO 2006)
Welcoming & Handling Customers
Dispensing Medicines as per prescription
Customer Counselling
Invoicing & inventory control
Regular Removal of Expiry
Excellent knowledge of Good Pharmacovigilance Guidelines (GVP) and ICH Guidelines, also good working knowledge of writing various kinds of safety documents
Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software (contributed in designing of aRMM tracking database)
Project management experience including the ability to prioritize, plan & evaluate deliverables; well organized and structured, strong attention to detail (Project handled for 50 RMP preparation in stipulated timelines including gap analysis and aRMMs for various clients)
Post Graduate Diploma in Clinical Research and Pharmacovigilance - from Cliniminds, Ahmedabad in 2014.
M. Pharm (Pharmaceutical Biotechnology),– from Ganpat University, Kherva, Gujarat in 2008
Research Paper: Maulik Suthar, Rakesh Patel, Kalindi Hapani, Avani Patel. Screening of Mallotus Phillipinensis for Antifungal Activity. Asian Journal of Microbiology, Biotechnology and Environmental Science; 2009 Volume 11; 535-541.
Harshil Patel, Kalindi Hapani, Jay Dave. Stakeholder’s perspective in implementation of additional risk minimisation measures: Reflection on challenges and solutions. Poster presented at ICPE ALL Access 2020, (Sep 16-17, 2020), held by International society of pharmacoepidemiology.
Harshil Patel, Kalindi Hapani, Jay Dave. “Safety and risk minimization on CAR-T cell therapies: US and EU perspectives”. Poster presented at ICPE ALL Access 2020 (Sep 16-17, 2020), held by International society of pharmacoepidemiology.
International Society of Pharmacoepidemiology (ISPE)
International Society of Pharmacovigilance (ISOP)
Nationality: Indian
Languages Known: English, Hindi, Gujarati
Marital Status: Single (divorced)
Date of Birth : January 3, 1980
Gender: Female
adhzuq@r.postjobfree.com
Ahmedabad, Gujarat India
LinkedIn URL: https://www.linkedin.com/in/kalindi-hapani-88358691/
I hereby declare that the information given above is genuine to the best of my knowledge & if you give an opportunity to work in your organization, I will put my best efforts.
Kalindi N Hapani
Place: Ahmedabad
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