Arifa Kadiri
Navi Mummbai
Summary
Accomplished master's prepared pharmacist with six years of pharmacovigilance experience in EV triage, case processing, handling training activities , quality assurance and people management. Expertise in managing ICSRs process as per international Pharmacovigilance regulations. Exceptionally organized and disciplined. Recognized consistently as a strong leader with a proven record of coaching individuals to success, making critical decisions during challenging times and seeking opportunities that further establish organizational goals.
Overview
6
6
years of professional experience
Work History
Pharmacovigilance Team Lead
Tata Consultancy Services
Mumbai
09.2020 - Current
- Workflow manager responsible for daily operations of twenty five employees and handling spontaneous case assignment along with approximately 200 ICSRs triage in Eudravigilance database.
- Contract management.
- Trainer and subject-matter expert (SME).
- Enhanced individual quality scores through one-on-one coaching.
- Participated in calibration sessions with the client to ensure alignment with quality expectations.
- Improved team related metrics through data extraction and analysis.
- Created and presented PowerPoint slide decks to internal and external stakeholders.
- Developed workflow maps for new and existing processes.
- Established and maintained healthy relationships with clients by assisting with resolution of issues, managing client expectations and providing exceptional client support.
- Performed duties as a pharmacovigilance and triage specialist.
- To ensure that the timelines of all the deliverables are met, keeping quality as a priority. Proactively identify and implement opportunities for process improvement and takes accountability for implementing the same.
- Drove operational improvements which resulted in improved service-level agreements and additional work.
Process Trainer
Tata Consultancy Services
Mumbai
08.2018 - 09.2019
- Assisted physicians and physician assistance in minor procedures.
- Offered patient education and advice related to and including pre- and post-operative instructions, medication administration, follow-up appointments and symptoms indicating emergency care.
- Accurate documentation of physical examinations.
- Train the staff as per training plan.
- Update the training plan and training materials as per requirement and maintain the vision control along with recorded sessions.
- Certify new candidates with help of POCs and Training and compliance team.
- Identify/ drive area for process improvement for the partnership (quality, efficacy, compliance).
- Stay up-to-date with respect to the assign process.
- Monitored compliance and evaluated effectiveness of training provided to team.
Information Process Enabler
Tata Consultancy Services
Mumbai
07.2017 - 08.2018
- Awarded "Learning achievement award" and "On the spot award" for outstanding service recognizant by a TCS.
- Responsible for instituting and maintaining the key aspects of drug safety.
- Triaging, Collecting, monitoring, processing and documenting of adverse reactions .
- Review, extract and accurately enter adverse event data from source including health professionals, sales representative, consumers and drug information in accordance with define case handling procedure.
- Interpret case related information including AE coding, medical conditions, lab results and procedures, as well as compile complete narrative summaries.
- Process and prepare reportable cases within applicable timeline including accurate determination of expectedness. Meet specific data and quality targets for case handling.
- Review, enter and verify follow-up information for cases, including correct identification of cases requiring targeted follow up. Review, enter and verify follow-up information for cases, including correct identification of cases requiring targeted follow up. Make significant contribution to project relating to improvement in process and systems.
- Processed more than 6000 ICSR including spontaneous, patient support programs, Market research programs and Non interventional studies.
- Handle quality review's position and perform quality check of CSR processed by case processor for accuracy and completeness.
Education
Master of Science - Masters in Pharmacy, Pharmacology
Mumbai University
Oriental College Of Pharmacy, Navi Mumbai07.2017
Bachelor of Science - Bachelors in Pharmacy
Pune University
Rajgad Dyanpeeth College Of Pharmacy, Pune04.2013
Skills
- Good Clinical Practice (GCP)
- Good Pharmacovigilance Practice(GVP)
- MedDRA coding
- ICSR Reporting
- Operational improvement
- Staff mentoring, training and development
- Time management
- Effective communication
- Conducting effective training
- Goal-driven
- Project management
- Detail-oriented
- Adaptable
- Collaboration
- Customer service
- Quick learner
- Workflow management
- Team leadership
- Data collection and analysis
- MS Office
Research experience
- Laxative activity of cledrodendrum serratum and root of in combination, Indian Research Journal of Pharmacy and Science, 3 (2), pp 610-615, 2016.
- Determination of laxative activity with content of anthraquinone glycosides from methanolic leaves extract of cledrodendrum serratum, International Journal of Pharmacy and Integrated Life Sciences, 4 (10), pp 19-30, 2016.
- Phyto-chemical and pharmacological review of cledrodendrum serratum (Bharangi), International Journal of Current Research, 8 (7), pp 3 4338-34341, 2016.
Key Attributes
- ICH guidelines on safety and efficacy
- GCP Modules
- FDA guidelines
- CIOMS
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)
Personal Details
Date of Birth: 14th May | Marital Status: Married | Nationality: Indian
Passport Number: P5418550
Address: 404, Bayt-Fatima, Sector 33, Plot no 37, Near NMIMS University, Kharghar, Navi Mumbai, Maharashtra-410210, India
Timeline
Pharmacovigilance Team Lead
Tata Consultancy Services
09.2020 - Current
Process Trainer
Tata Consultancy Services
08.2018 - 09.2019
Information Process Enabler
Tata Consultancy Services
07.2017 - 08.2018
Master of Science - Masters in Pharmacy, Pharmacology
Mumbai University
Bachelor of Science - Bachelors in Pharmacy
Pune University
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