Safiya Qureshi

Registered Pharmacist currently working as a clinical research coordinator for genetic testing, oncology and new treatment & diagnostic procedures. Holding 5yrs of experience in medical and pharmaceutical industry. Exhibit strong knowledge and experience in Clinical research, Drug and cosmetic safety & Regulatory affairs. Work Experience:

1. Clinical Research Coordinator At MHP Comprehensive Urology in RoyalOak, Michigan (Mar’23-Current).

• Supported Lead data manager (LDM) and worked as a cohesive team member in coordinating assigned clinical studies while adhering to the principles of ICH and Good Clinical Practice (GCP).

• Obtained thorough understanding of the research protocol to run clinical reports & screen potential patients. Assisted in enrolling potential subjects including introducing study purpose and provide informed consent form (ICF) as per IRB.

• Handled and maintained inventory accountability for all study supplies and investigation products.

•Answering study participants queries and aiding survey completion. Demonstrated knowledge to identify and report Adverse Events (AEs) to the LDM.

• Document and maintain study related procedures and events on Case report forms (CRF) or electronic data capture (EDC) like electronic trial master file (eTMF), Redcap, MediDATA in a timely manner.

• Arrange and take part in weekly client meetings to track study progress. Prepare for and participate in sponsor and external regulatory audits and departmental audits, including review of study and regulatory documents for accuracy and completeness. Participated in Team meetings with research manager in budget negotiation, patient compensation and initial site visits with Sponsor.

2. Cosmetic safety and regulatory claims specialist At Loreal, Clark, New Jersey (Apr’22-Dec’22)

• Intake and review of adverse events of cosmetic and OTC drugs from salesforce to Argus safety database. Case entry and coding events and drugs/cosmetics using MedDRA and WHO drug/CDD terminology and review comprehensive narrative.

• Identified PQC issues and request investigations from plants as required. Performed daily vendor database queries and provide notification to business partners.

• Ensured the prioritization, completion, accuracy & validity for initial and follow-up Adverse Events (AEs) for both OTC Drugs

& Cosmetic products in compliance with company Standard Operating Procedures (SOPs) and any applicable global regulatory guidelines.

• Reviewed and completed medical assessments and determined seriousness criteria for cases involving both OTC Drugs & Cosmetic products while prioritizing workload for OTCs& Hospital visit cases.

• Prepared serious expedited MedWatch Reports and/or perform Quality Assessment and ensure timely submission to the FDA.

• Reviewed and educated teams on CSAR, Chinese cosmetic regulations and FDA regulations on OTC drugs and cosmetics 21 CFR 352.1- 352.77 and 21 CFR 700-799 which included registration, cosmetic labeling and adverse event reporting.

• Facilitated cross functional collaboration in US, China and France.

• Resolving queries related to efficacy testing requirements and artwork modification. Verifying dossier readiness for China regulatory submission.

3. Registered Pharmacy Intern at My Pharmacy NJ, USA (Jan’21-Apr’22):

• Adhered to company policies and procedures while performing duties assigned by the Pharmacist such as utilizing pharmacy systems to enter PHI and drug information, ensuring information is entered correctly, filling prescriptions by retrieving, counting, pouring pharmaceutical drugs, verifying medicine is correct and checking for possible interactions.

• Engaged patients by helping, resolving issues and answering questions on incoming and outgoing calls to ensure a positive customer care experience.

• Initiated outbound calls to physician’s office for refill requests, facilitating prior authorization and seek assistance in drug rejections.

• Proactively participated in improving the workflow and train new technicians and pharmacists to complete tasks.

• Assisted Pharmacist in charge (PIC) in insurance and board audits, license and renewal contracts 4. Patient Care Coordinator at Asembia Specialty Pharmacy, NJ,USA.(May’20- Jan’21)

• Received and effectively route program “referrals” (prescriptions) and initiate a ticket for queries.

• Handled high volume of inbound and outbound Patient and physician calls to obtain any product query or complaint. Entering and reviewing queries/complaints in the database.

• Timely check on voicemail box, emails and faxes on product complaints and identifying and take steps to resolve any issues.

• Studying the use of the product to educate patients and assist them in providing timely delivery of the product

• Research financial assistance options for patients through copay cards, foundations, and assistance programs.

• Provided subject matter expertise in case management and related procedures. 5. Certified Pharmacy technician Rite Aid Pharmacy (Nov’19-Apr’20)

• Received, entered and filled prescriptions. Maintained and filed physician orders and prescriptions.

• Provided manufacturer coupons for processing brand medications to offer savings program to patients.

• Supported pharmacy with stocking and pricing of medications in inventory and ensuring availability of drugs by delivering them to patients or facilities.

• Responsible and accountable for registering all related sales on assigned cash register, collects and handles cash as required.

• Scheduled prescription deliveries while maintaining delivery log and uploading delivery tickets. 6. Drug safety associate At Accenture, in Hyderabad, India (Sept'18-oct’19) Individual case safety experience:

• Receive, triage, the data to perform book in and data entry into Argus database safety database, coding relevant medical terminology using MedDRA and WHO drug/CDD terminology, writing comprehensive narratives, generating queries, performing quality control, assisting with reconciliation, driving case closure, coordinating translations, and ensuring reports are sent to the customer within assigned deadlines.

• Identify and select routine cases for processing, determining prioritization criteria, and noting reasons for any delays and identifying duplicate reports by searching safety database.

• Perform literature search, review case entry, process and document: event terms, medical history, laboratory data, co suspects, and case classifications (validity, seriousness, and expectedness/listedness/labeledness); product complaint information; reportability with due date; and accuracy and consistency

• Generate line listings and request all pertinent follow up information from reporters for the completion of case reports within specific timelines as prescribed by global regulations and SOPs. Aggregate experience:

• Contributed and drafted safety sections of aggregate safety documents like PBRERs (section 5.2, 9.2 and 9.3)

• Analyzed data, reviewed, contributed to drafting AD-hoc responses to health authorities, with oversight Signal Detection experience

Published Research:

1. Ghori,K;&Junaid,A;&Rahman,A;&Sumana,Safiya;&Ansari,Javed(2015).Clinical observational and Prospective Study of effect of Cardiovascular and Neuroprotective Drugs On Stroke Patients in a tertiary care hospital for a duration of six months (2015). Education and Professional Licenses:

Registered Pharmacist ’22, NJ.

Degree: Pharm D, Osmania university 2017’ Hyderabad’ India. Knowledge, Skills and Abilities:

• Exhibits knowledge about IRB, GCP, ICH, TMF, FDA regulations on Drugs for human or animal use, medical devices, clinical trials (phases 1,2 & 3) and biologics. Familiar with CTD, IFU and drug applications (NDA,BLA, 510 k submissions).

• Compassionate, agile and a team player.Exceptional quick learning skills with keen interest in learning new software platforms

• Ability to multitask and handle stressful situations with excellent organizing skills and time management to meet deadlines. Strong medical terminology and knowledge.

• Possess impressive teaching and training skills and enjoy mentoring others.

• Proficiency in Adobe, Salesforce, Oracle-Argus database, EMR systems, outlook, sharepoint, Medidata, redcap, electronic trial master file, Teams and MS Office Suite applications. Address: Farmington hills, Michigan, 48334. Email: ad0alj@r.postjobfree.com Phone: 908-***-**** Anne Borelli, RN

Director – PMS

Claims & Microbiology -Americas

Office: 732-***-****

133 Terminal Ave

Clark, NJ 07066 USA

Dear Sir or Madam,

I am writing this letter to recommend Safiya Qureshi for Drug Safety Position at your organization. Having known Safiya for an year, I have only positive things to say about her both personally and professionally.

Safiya's position was Cosmetic safety and regulatory claims specialist in the post marketing safety department at L'Oreal USA based in Clark, NJ. I was her direct supervisor for the time she was employed with L'Oreal. Safiya possesses a unique combination of skills that make her an outstanding candidate for the drug safety position. She has a strong background in Pharmaceutical Industry and her expertise in Pharmacovigilance and regulatory is truly commendable. Safiya instantly developed a thorough understanding of cosmetic regulations and collaborated with other teams. Safiya was efficient at performing medical assessments of adverse event cases and SAEs that would be submitted to Regulatory Authorities. Furthermore, Safiya is known for her high level of integrity, professionalism, and reliability. She approaches her work with a proactive mindset and is always willing to go above and beyond to achieve optimal results. Her positive attitude and willingness to take on new challenges make her a valuable asset to any team. She always came to work with a positive attitude and this was contagious through other departments as well. Please feel free to contact me with any questions or requests. Best Regards,

Anne Borelli, RN

Director – Post Marketing Surveillance

Claims & Microbiology – L’oreal Americas

Email : ad0alj@r.postjobfree.com

Letter of Recommendation

To whom it may concern,

I am writing to highly recommend Safiya Qureshi for a position at your esteemed company. During her tenure as a clinical research coordinator at Comprehensive Urology, Safiya consistently demonstrated outstanding performance and dedication to her work, making her an invaluable asset to our team. Safiya's ability to quickly grasp complex concepts and her impressive organizational skills set her apart from her peers. She approaches tasks with intelligence, precision, and a positive attitude that is truly infectious. Her cheerful personality not only brightens the workplace but also fosters a collaborative and enjoyable atmosphere among her colleagues.

One of Safiya's greatest strengths is her capacity to work effectively within a team. She actively engages with her peers, offering support, sharing knowledge, and contributing valuable insights. Her proactive approach and willingness to go the extra mile significantly enhance the team's overall productivity and cohesion.

As a manager, I found Safiya to be a reliable and dedicated professional. Her exemplary work ethic and positive demeanor make her a pleasure to work with. I have no doubt that Safiya's exceptional skills, coupled with her passion for her work, will make a significant contribution to any team and project she becomes a part of.

I am confident that Safiya Qureshi will excel in any role she takes on, and I wholeheartedly recommend her for employment at your organization. If you require any further information or have questions, please do not hesitate to contact me at.

Thank you for considering my recommendation. I have no doubt that Safiya will bring the same level of dedication and excellence to your organization as she did to ours. Sincerely,

Tarek Sangid, M.D., CTPM

Clinical Research Director

E: ad0alj@r.postjobfree.com

9/29/2023

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