Yyyyyy x. yyyyyy

Xxxxxx, MI xxxxxx ￨ (xxx-xxx-xxxx ￨ abc@xyz.com

Highly Accomplished Leader who offers proven experience in Pharmacovigilance, Medical Affairs Management, FDA Audit Processes / Procedures, and Corporate Compliance, as well as a background in Retail / Hospital Pharmacy Operations, Team Building / Training, Budget Control, Inventory Management, and Customer Service. Visionary Professional who maintains up-to-date knowledge of pharmaceutical industry operations, and who quickly adapts to evolving scenarios while independently resolving in-depth issues to boost success. Dedicated Self-Starter who contributes superior attention-to-detail and sharp analytical abilities to meet critical pharmacovigilance and regulatory compliance objectives. Multilingual Communicator (English, Macedonian, Serbo-Croatian) who handles confidential responsibilities while liaising between decision-makers, healthcare teams, agencies, and customers, and who surpasses expectations in autonomous or collaborative environments.

Career Highlights Include:

  Demonstrating an in-depth understanding of optimal drug safety practices.

  Ensuring strict compliance with internal / external regulatory reporting timelines.

  Gaining a reputation among colleagues for expert review of adverse events and complaints.

  Exhibiting scientific clinical base and domestic and international drug regulations knowledge.

  Seamlessly liaising among manufacturing sites, corporate quality, administrators, and practitioners.

Medical Affairs Manager ￨ Senior Manager Corporate Compliance

Capitalize on the opportunity to contact reporters for follow-up information and procurement of complaint samples for complaints classified as ADE+PQCs. Optimize administrative efficiency by maintaining a complex, highly detailed complaint database. Prepare comprehensive, complaint-specific response letters to both customers and the Agency s MedWatch / Drug Quality Reporting System.

  Successfully review Investigation Reports for completeness and accuracy.

  Interface between multiple manufacturing sites and Corporate Quality in India.

Medical Affairs Manager

Strategically steered review and processing of adverse event reports, including assessing reports for seriousness and expectedness, contacting reporters for follow-up information and procurement of complaint samples, and maintaining a detailed and accurate complaint database. Objectively reviewed Investigation Reports for completeness and accuracy. Demonstrated skill in preparing customer response letters and preparing and submitting 15-Day Alert Reports and Periodic Adverse Drug Experience Reports to the FDA. Submitted response letters to Agency s MedWatch / Drug Quality Reporting System in alignment with strict policies and procedures.

  Prepared comprehensive Health Hazard Evaluations per key guidelines.

  Passed multiple FDA pharmacovigilance inspections with zero FDA 483 observations.

  Passed multiple FDA Audits of the complaint handling system as part of on-site GMP audits.

  Served as an integral liaison between manufacturing sites and India-based Corporate Quality.

Pharmacist

Promoted a quality-focused retail pharmacy operations environment, including training and managing a team of 3 technicians per shift. Managed the pharmacy budget per strict federal guidelines and state laws, along with overseeing billing operations, ordering and purchasing, weekly reporting, and recordkeeping. Expertly dispensed drugs and medical supplies prescribed by doctors and dentists, and compounded topical and oral preparations.

  Routinely communicated with up to 700 customers weekly.

  Developed and implemented policy / procedure improvements.

  Streamlined workflow, increased efficiency, and enhanced productivity.

  Personally monitored therapeutic outcomes of patients to deliver optimal services.

  Liaised among area physicians to resolve prescription and / or customer health concerns.

Yyyyyy x. yyyyyy ￨ Page Two ￨ (xxx-xxx-xxxx

Pharmacist

Applied strong leadership talents toward driving high-volume pharmacy business initiatives, including continually ensuring compliance with all federal; state; and St. John Health System guidelines, policies, and procedures to meet and / or exceed hospital-wide goals. Expertly verified unit dose medications, IV therapeutics, TPNs, and chemotherapy drugs, along with offering proficiency in the compounding of topical and oral preparations.

  Successfully processed 200+ average orders daily with accuracy.

  Collaborated with anesthesiologists, surgeons, and specialty practitioners.

Pharmacy Technician ￨ Intern

Played a vital role in accurately preparing billings for service fees, including maintaining detailed and accurate records while conducting inspections of pharmaceutical storage and delivery at nursing units. Expertly prepared intravenous add-mixtures, including chemotherapy products and TPNs. Delivered controlled substances to nursing units while contributing sharp analytical abilities toward maintaining a high-volume inventory.

  Proactively attended and participated in business and pharmacy meetings.

  Served as a go-to information resource for administrators, providers, and customers.

  Efficiently compounded topical preparations and assisted with filling high-volume prescriptions.

Doctor of Pharmacy Wayne State University

Bachelor of Science in Allied Health Sciences (Presidential Scholarship) Wayne State University

Associate of Science in Applied Science (Summa Cum Laude) Oakland Community College

Licensed Pharmacist ￨ Licensed Controlled Substance Pharmacist Xxxxxx Board of Pharmacy

Introduction to Hospital Pharmacy (St. Joseph s Mercy Hospital)

Pediatrics Inpatient and Outpatient (Children s Hospital of Xxxxxx)

Drug Information (Detroit Receiving Hospital & University Health Center)

Introduction to Community Practice (Meijer) ￨ Customer Service (Rite Aid)

Internal Medicine Stroke and Geriatric Unit (Rehabilitation Institute of Xxxxxx)

Surgery / Critical Care Rotation (Detroit Receiving Hospital and University Health Center)

Cardiothoracic Surgery (Harper University Hospital) ￨ Clinical Research (St. John Hospital & Medical Center)

Formulary Review: Aripiprazole (2003)

Drug Class Review: Oxybutynin vs. Tolterodine (2003)

Review: OTC and prescription medications used for weight loss (2002)

Chart review & medication use evaluation of Drotrecogin alfa (Xigris) (2003)

Literature Review: The Safety and Effectiveness of Topical Antibiotics Used in Otitis Media (2002)

Vaccine Review: Summary of active & inactive ingredients in commonly used vaccine products (2002)

Pulmicort Respules, Detroit Children s Hospital (2002)

Growth and Development, Wayne State University (2002)

Bronchopulmonary Dysplasia, Wayne State University (2002)

Drotrecogin alfa (Xigris), St. John Hospital and Medical Center (2003)

Activated Protein C and Its Use in Severe Sepsis, Wayne State University (2002)

Arginine and its Role in Treating Critically Ill Patients, Wayne State University (2003)

Alcoholism, Alcohol Withdrawal, and Pancreatitis, St. Joseph s Mercy Hospital (2002)

Pharmaceutical Products Manufactured by Recombinant DNA, Wayne State University (2001)

Excellent Professional References Provided Upon Request

Yyyyyy x. yyyyyy

Xxxxxx, MI xxxxxx ￨ (xxx-xxx-xxxx ￨ abc@xyz.com

Date

Hiring Agent Name

Company Name

Address

City/State/Zip Code

Dear__________________:

I am exploring a new career opportunity within a challenging [ Insert Job Title ] role, and I believe that I can make a positive contribution to your success.

As a Licensed Pharmacist in the State of Xxxxxx, I can offer proven experience in Pharmacovigilance, Medical Affairs Management, FDA Audit Processes / Procedures, MedWatch / Drug Quality Reporting Systems, and Corporate Compliance. I am also highly skilled in Retail / Hospital Pharmacy Operations, Team Building / Training, Budget Control, Inventory Management, Safety / Quality Assurance, Data / Records Management, and Customer Service, among other areas.

To complement this experience, please note that I earned a Doctor of Pharmacy and Bachelor of Science in Allied Health Sciences from Wayne State University. I also hold an Associate of Science in Applied Science and a Certificate in Hospital Pharmacy Technology from Oakland Community College. As aforementioned, I am a Licensed Pharmacist and Licensed Controlled Pharmacist by the Xxxxxx Board of Pharmacy.

Currently, as a Medical Affairs Manager / Senior Manager of Corporate Compliance for Sun Pharmaceutical Industries, Inc., I expertly contact reporters for follow-up information and procurement of complaint samples for complaints classified as ADE+PQCs. Within this role, I also successfully maintain a complex, highly detailed complaint database to optimize administrative efficiency. Furthermore, I prepare comprehensive, complaint-specific response letters to both customers and the Agency s MedWatch / Drug Quality Reporting System, and regularly interface between multiple manufacturing sites and Corporate Quality in India.

Prior to this, as a Medical Affairs Manager for both Caraco Pharmaceutical Laboratories, Ltd. and Sun Pharmaceutical, I strategically led efforts to pass multiple FDA pharmacovigilance inspections with zero FDA 483 observations, as well as multiple FDA Audits of the complaint handling system as part of on-site GMP audits.

As this is just an example of my abilities, please refer to my enclosed resume for additional experience, professional training / development, research, and presentations.

I am eager to discuss how my qualifications uniquely match your current and future needs, and look forward to interviewing with you soon.

Sincerely,

Yyyyyy x. yyyyyy