Hira Tamkeen
Acton
Summary
Extensive experience in clinical research and pharmacovigilance, specializing in medical review and safety evaluation of promotional materials. Expertise in analyzing clinical data, ensuring compliance with regulatory standards, and supporting risk mitigation. Proven ability to communicate findings effectively across teams, facilitating informed decision-making and maintaining patient safety.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Community Residential Counselor
Mclean Hospital
Belmont
05.2024 - Current
- Facilitated and supervised community activities tailored to individual needs.
- Assisted patients in scheduling and attending various appointments.
- Promptly communicated observations regarding medication side effects and physical or emotional changes to the appropriate medical staff.
- Motivated patients to actively participate in their activities of daily living.
- Oversaw patient activities and guided to ensure safety and compliance.
Sr Clinical Research/Safety Scientist
JNJ MedTech
Danvers
08.2022 - 02.2024
- Interpreted and communicated clinical trial data effectively to cross-functional teams, ensuring alignment of medical strategies with overall clinical development plan objectives.
- Oversaw the review and reporting of adverse events (AEs) and serious adverse events (SAEs) across multiple clinical trials, ensuring compliance with regulatory requirements and timelines.
- Analyzed post-market complaint data to identify potential product issues and assess safety signals for proactive risk management.
- Supported the submission of aggregated data reports, including Periodic Safety Update Reports (PSUR) and Clinical Evaluation Reports (CER).
- Orchestrated clinical evaluation meetings in collaboration with stakeholders, managing narrative writing and overseeing post-meeting activities such as data entry and resolution of discrepancies.
- Conducted comprehensive data review and analysis of research findings, identifying discrepancies and irregularities to uphold data integrity and validity.
- Performed clinical trial protocol revisions while ensuring compliance with Good Clinical Practice (GCP) standards in collaboration with stakeholders.
- Generated scientific content, conducted thorough literature reviews, and managed regulatory submissions, including annual and final submissions as well as the approval of new indications for medical devices.
- Verified and approved medical content for accuracy, ensuring correctness in marketing and promotional documents.
- Contributed to the development of global tools and standards, including training modules, work instructions, templates, and standard operating procedures (SOPs).
- Facilitated internal audits, vendor inspections, and the development of post-audit corrective action plans (CAPA).
Medical Research/Pharmacovigilance Associate
Abiomed
Danvers
07.2019 - 02.2022
- Supported the reporting of adverse events (AEs) and serious adverse events (SAEs) during clinical trials, ensuring adherence to regulatory requirements and timelines.
- Interpreted and communicated clinical trial data to cross-functional teams, ensuring that medical strategies were aligned with the objectives of the overall clinical development plan.
- Facilitated clinical evaluation meetings with stakeholders, managing narrative writing, and coordinating post-meeting activities such as data entry and resolution of discrepancies.
- Conducted comprehensive literature searches and reviews, maintained a literature library, and prepared scientific material for publication.
- Reviewed and analyzed research data to maintain integrity and validity, identifying discrepancies and irregularities as needed.
- Supported clinical trial protocol revisions and submissions, while ensuring compliance with Good Clinical Practice (GCP) standards.
- Verified and approved medical content to guarantee accuracy in marketing and promotional documents.
- Reviewed source documents, case report forms, patient records, and the electronic trial master file (eTMF) to ensure data accuracy and completeness across multiple clinical trials.
- Contributed to the development of global tools and standards, including training modules, work instructions, templates, and standard operating procedures (SOPs).
- Monitored the accuracy and completeness of medical records in the electronic data capture (EDC) system and retrieved incomplete records as necessary from sites.
- Conducted clinical data abstraction from medical records for research purposes.
Community Residential Counselor
Mclean Hospital
Belmont
11.2017 - 07.2019
- Facilitated and supervised community activities tailored to individual needs.
- Assisted patients in scheduling and attending various appointments.
- Promptly communicated observations regarding medication side effects and physical or emotional changes to the appropriate medical staff.
- Motivated patients to actively participate in their activities of daily living.
- Directed and supervised patients as necessary.
Mental Health Tech/Specialist
Mclean Hospital
Belmont
04.2015 - 08.2017
- Delivered direct care to patients with psychiatric disorders and actively participated in therapeutic milieu activities.
- Assisted in the treatment and care of patients diagnosed with psychiatric disorders, trauma, and borderline personality disorders.
Clinical Observer/ Volunteer Research Associate
Boston Medical Center
Boston
10.2012 - 03.2015
- Assisted in the development of study protocols, maintained study logs, and liaised with the Institutional Review Board (IRB).
- Administered neuropsychological assessments to study participants accurately.
- Conducted data entry of source documentation in compliance with standard operating procedures (SOPs).
- Performed follow-up actions for missing, discrepant, or additional information from source documentation effectively.
- Collaborated closely with physicians and other study staff to evaluate and manage study subjects efficiently.
- Managed communications, both written and telephonic, with physicians and other healthcare professionals.
- Assisted in analyzing medical cases to deepen understanding of clinical medicine applications in real-life scenarios.
Health Consultant
Kitchen Magazine
Karachi
01.2007 - 07.2012
- Conducted extensive literature searches and supported publication efforts.
- Addressed client inquiries online, via phone, and in person.
- Performed proofreading and editing for articles published in the magazine.
Medical Doctor
Abbasi Shaheed Hospital-CDGK
Karachi
08.2010 - 07.2011
- Assisted in various surgical procedures and outpatient clinic activities under supervision.
- Developed diagnoses, treatment plans, and follow-up procedures.
- Conducted daily clinical rounds and prepared comprehensive reports.
- Performed phlebotomy, catheterization, lumbar punctures, and paracentesis procedures.
- Participated in weekly medical conferences for clinical education.
Education
MBBS - Medical Doctor
Hamdard College of Medicine
Karachi, PK06-2010
Skills
- Analytical Skills
- Attention to Detail
- Clinical Research
- Collaboration
- Communication skills
- Critical Thinking
- CRM
- Data Management
- EndNote
- HIPAA
- Interpersonal Skills
- MedDRA
- Medical Terminology
- Medidata
- Organizational skills
- Patient Safety
- Pharmacovigilance
- Problem Solving
- Protocol Development
- Quality Improvement
- Regulatory Requirements
- Team player
- Time Management
- Treatment Planning
- IRB Protocol
- MS Office
- Wrike
- Veeva Vault
- EDC database
- Argus
- Safety Database
- Signal Detection
- Clinical Trial Development
- Informed Consent Process
- GCP standards
- Literature Search
- ICSR Process
- Active Listener
- Supervision
Certification
- Project Management: foundation and Initiation, University of Colorado Boulder, 05/25
- Patient Safety and Quality Improvement: Developing a System View (Patient Safety), John Hopkin University, 02/25
- Medical Device Post Market Surveillance Implementation Training, OrielStat A Matrix, 05/21
- Medication Administration Program Certified, Mass.gov, 10/17
- Good Clinical Practice - Clinical Operations, CITI Program, 02/21
- Fellowship- Psychoanalysis, Boston Psychoanalytic Society and Institute, 08/16
- CPR, American Red cross, 02/15
- ECFMG Certified, Education Commission Of Foreign Medical Graduate, 07/14
- License to Practice- Certificate Of Full Medical Registration, Pakistan Medical and Dental Association, 08/11
Languages
- Hindi
- Urdu
- English
Timeline
Community Residential Counselor
Mclean Hospital
05.2024 - Current
Sr Clinical Research/Safety Scientist
JNJ MedTech
08.2022 - 02.2024
Medical Research/Pharmacovigilance Associate
Abiomed
07.2019 - 02.2022
Community Residential Counselor
Mclean Hospital
11.2017 - 07.2019
Mental Health Tech/Specialist
Mclean Hospital
04.2015 - 08.2017
Clinical Observer/ Volunteer Research Associate
Boston Medical Center
10.2012 - 03.2015
Medical Doctor
Abbasi Shaheed Hospital-CDGK
08.2010 - 07.2011
Health Consultant
Kitchen Magazine
01.2007 - 07.2012
MBBS - Medical Doctor
Hamdard College of Medicine