DANIAL HASSAN

** ******* ***, ****** **- 518-***-**** adyxki@r.postjobfree.com

SUMMARY

• Pharmacovigilance professional with 8 years of experience in Drug Safety and Pharmacovigilance, and 5 years in clinical research.

• Proficient in authoring and auditing medical summaries, event reports, protocols, and consents.

• Effective contributor to drug safety initiatives utilizing expertise in regulatory compliance and risk management.

• Demonstrated ability to ensure patient safety and promote public health by identifying and managing adverse drug reactions and other drug-related problems.

• Experienced in managing reporting requirements for Adverse Events and Serious Adverse Event reports, preparing reports for electronic submission via the FDA Adverse Event Reporting System (FAERS).

• Therapeutic Specialties: Internal Medicine, Cardiology, Surgery, Pediatric, Oncology SKILLS

• ICH-GCP

• Clinical Trial Life Cycle

• Research Ethics

• Treatment and Diagnosis

• Medical Monitoring

• Identification of AEs/SAEs

• Pharmacovigilance

• Auditing

• Medical Review

• Adverse Drug Reaction

Monitoring/Reporting

• Narrative Writing

• Signal Detection and

Management

• Risk Assessment/Risk

Management Plans

• Regulatory Guidelines

• Safety

Communication/Reporting

• Safety Databases: Argus,

ArisG, Oracle

• Pharmaceutical

Products/Practices

• Documentation/Records

• Schedule Management

• Facilities Assessment

• Public Health

Inspection/Audit

• Investigation/Corrective

Action

• Microsoft Office Suite

• CTMS

• Medidata

• Cerner

• Oracle

• Argus

• SPSS

• Stata

PROFESSIONAL EXPERIENCE

MediPharm Solutions. NJ (01/2023 – Current)

Drug Safety and Pharmacovigilance Specialist (Contract)

• Responsible for collecting, analyzing, and evaluating data regarding the safety profile of drugs and healthcare products throughout their lifecycle.

• Identifying and assessing adverse events, monitoring the benefits and risks associated with the use of medications, and implementing risk management strategies to minimize harm.

• Proficient in safety databases such as Oracle Argus Safety and ArisG safety, and excellent analytical skills in disease diagnoses, drug-event combinations, and drug-drug interactions.

• Reviewed spontaneous reports as well as cases from clinical trials for marketed and investigational compounds to determine regulatory reporting responsibilities.

• Accurately and timely entered domestic and foreign adverse event information into the PSSS (Product Safety Surveillance System) using the ARISg coding manual, SOPs/WIDs, and established time frames.

• Prepared adverse event reports from all sources including post-marketing spontaneous, published literature AE and SAE as well as clinical trial AE and Suspected Unexpected Serious Adverse Reaction (SUSAR) cases.

• Processed serious adverse event information per the sponsor’s standard operating procedures (SOPs).

• Submitted ICSRs to the regulatory authorities within timelines for compliance.

• Performed medical coding using MedDRA and WHO DD. DANIAL HASSAN

14 Simmons Ave, Cohoes NY- 518-***-**** adyxki@r.postjobfree.com

• Monitored electronic mailboxes to ensure timely acceptance of Adverse Event (AE) Reports and performed data entry into databases, as needed.

• Generated queries to obtain missing case information for a complete assessment.

• Performed quality review for adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs).

• Performed SAE reconciliation on a periodic basis and at DLP.

• Performed appropriate clinical assessments and ensured compliance with global regulatory reporting requirements.

• Performed triage of incoming reports of clinical/solicited/spontaneous sources for completeness, legibility, and validity.

• Raised SAE queries to investigative sites, and CRAs as needed.

• Prepared clinical narrative summaries for SAE reports independently from clinical studies and spontaneous post- marketing reports in the Argus database.

• Queries related to safety events are reconciled with the data management team and resolved timely.

• Performed quality review of individual case safety reports and for providing feedback to team members, working closely with the Case Processing team and Medical Reviewers to ensure complete and accurate information has been entered into the safety database.

• Authored individual case assessment summaries and narratives, investigational and marketed product Periodic Safety Update Reports, protocols, and Annual Reports.

• Interpreted aggregate safety data; determine the potential impact of safety data on product labeling or development status of investigational compounds.

• Accept E2B cases received through the Argus Electronic Submissions Module (ESM).

• Monitor electronic mailboxes and Argus ESM to ensure timely acceptance of Adverse Event (AE) Reports and perform data entry into databases, as needed.

• Developed, authored, and managed safety documents, such as Pharmacovigilance Plans and Risk Management plans submitted to the FDA and to the EMA.

• Managed requirements for electronic submissions to the FDA Adverse Event Reporting System (FAERS).

• Developed complete responses to FDA inquiries regarding investigational and marketed product safety which presented accurate benefit-risk information and supported company initiatives.

• Completed all required training within provided timelines to stay up to date on corporate and departmental SOPs, SWPs, and WIDs.

Ministry of Public Health: Department of Healthcare Profession. (11/2015 –Current) Medical Monitoring Specialist-Remote

• Served in the Ministry of Public Health, responsible for governing the competency and fitness of health sector professionals.

• Fulfilled a research-driven role investigating Adverse Events in private and public sector hospitals across the country in the form of Competency and Fitness to Practice Evaluations.

• Continuously drove process improvements in patient safety and quality of care.

• Received and triaged adverse event reports from various sources, including healthcare professionals, patients, and literature.

• Utilized skills in pharmacovigilance, risk assessment, and patient safety advocacy to investigate drug-related complaints through the evaluation of adverse drug reactions (ADRs), review of patient records, interviews with patients and healthcare professionals, and presenting informed conclusions on cases. DANIAL HASSAN

14 Simmons Ave, Cohoes NY- 518-***-**** adyxki@r.postjobfree.com

• Collaborated with cross-functional teams, including medical affairs, clinical research, regulatory affairs, and ministry associates to promote drug safety and pharmacovigilance, ensuring effective pharmacovigilance practices throughout the product lifecycle.

• Generated safety reports, such as periodic safety update reports (PSURs) and expedited reports.

• Reviewed the policies and procedures of primary and tertiary care healthcare institutions suggesting improvements to

• maximize patient safety and quality of care.

• Drafted new policies and procedures for hospitals to accommodate changes in the healthcare landscape, including major events such as COVID-19.

• Developed and implemented risk management plans (RMPs) to mitigate identified risks.

• Ensured compliance with pharmacovigilance regulations and guidelines, including Good Pharmacovigilance Practice

• (GVP).

• Participated in internal and external audits and inspections related to drug safety and pharmacovigilance.

• Upheld the department’s purpose to provide a fair and informed voice for the patient in cases where healthcare quality and patient safety are compromised.

• Reviewed and comprehended KPIs and other forms of data revealed using statistical software packages.

• Measured practitioner competency against formal frameworks to ensure quantitative substance behind the evaluation.

Clinical Research Fastrack. AZ (01/2020 – 06/2020) Clinical Research Associate

• Maintained data integrity and properly recorded all information for clinical trials, including adhering to documentation protocols regarding adverse events (AEs) and safety.

• Reviewed and maintained source documents, FDA forms and procedures, and FDA/IRB submission binders.

• Familiarity with regulatory requirements including FDA regulations 21 CFR 11, 50, 54, 56.

• Managed required documentation protocols to initiate and close clinical trials.

• Evaluated process preparing for site audits and implementing corrective measures to ensure compliance with documentation, drug compliance, storage, and other regulatory protocols.

• Provided input on protocol design and created medical monitoring plans utilized for safety procedures throughout the trial.

• Developed in-depth project plans for clinical trials, outlining the relevant documentation, requirement quotas, deadlines, and objectives to ensure seamless completion.

• Reviewed all management tactics and close-out procedures for clinical trials.

• Formulated candidate recruitment plans utilizing channels such as social media to promote trial awareness.

• Leveraged incentives to compensate participants accordingly.

• Managed concepts such as informed consent, participant education, and driving retention.

• Prepared documents for required audits, developing experience with essential documents (1572, DOA, Logs, etc).

• Prepared SAE/AE reporting documents for electronic submission into the FDA Adverse Event Reporting System

(FAERS).

Dr. Moopen Aster Hospital. Dubai (09/2017 – 05/2023) Physician (Part-Time)

• Utilized clinical skills as a practicing physician to serve a diverse patient demographic of approximately 50-60 patients weekly.

DANIAL HASSAN

14 Simmons Ave, Cohoes NY- 518-***-**** adyxki@r.postjobfree.com

• Provided treatment and guidance related to various health conditions typically addressed by a family practice.

• Responsible for close monitoring and management of indoor patients/ICCU/NICU.

• Handled patients with chronic diseases by recording patients’ medical history and conducting physical examinations.

• Undertook routine and diagnostic investigations as needed.

• Ensured administration of appropriate drugs to patients and handled patient counseling sessions.

• Assisted the Physicians and Surgeons and participated in Case Discussions, Feedback about the Patients, and the Treatment Imparted.

• Ascertained that quality health services were provided at the best possible levels through the optimum usage of available resources at the Hospital.

• Handled Medical/Surgical Emergencies and Trauma Cases along with emergencies.

• Managed OPD patients and carried out day-to-day surgical procedures in OBS-Gynecology, and family planning.

• Effectively performed procedures including Central Line insertion, Temporary Pacemaker, E.T. Intubation and Ventilation, Chest Drain, Peritoneal Drain, and Airway Management.

• Maintained patient confidentiality when handling medical documents.

• Communicated effectively with patients to explain medical terminology in laymen’s terms. Formal Education

Master of Science in Clinical Research (MSc) 2020

Dresden University – Germany

Thesis: "Psychosocial Risk Factors in Cardiovascular Disease: A Study on Individuals aged 35-40 in Qatar" International Society of Health Care 2015

Fellowship in Patient Safety (FISQua)

Principles & Practices of Clinical Research (PPCR) • Advanced Statistics Workshop • Scientific Research Writing 2018 Harvard T.H. Chan School of Public Health, Harvard Extension School – Boston, MA, USA Bachelor of Medicine, Bachelor of Surgery (Equal to MD) 2015 Hospital of Zhengzhou University – China

LICENSES/ CERTIFICATIONS/MEMBERSHIP

Advanced Drug Safety and Pharmacovigilance Certification 2023 Affiliated Member of the American College of Epidemiology 2022 Clinical Research Associate, Fast Track 2020

Licensed Medical Doctor in Qatar 2020

Root Cause Analysis 2018

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