Melvina Samuel
Bolton,Lancashire
Summary
Dedicated pharmaceutical professional with extensive experience in medical information, pharmacovigilance, and quality management. Skilled in delivering exceptional customer care by confidently and accurately responding to enquiries from healthcare professionals, patients, and the public in compliance with regulatory standards such as ABPI and MHRA guidelines. Proficient in handling complex enquiries, adverse event reporting, and product quality complaints. Demonstrated expertise in managing Quality Management Systems (QMS), including authoring and revising SOPs, conducting internal audits, and implementing corrective and preventative actions. Worked closely with cross-functional teams to support quality standards and successful product launches.
Overview
4
4
years of professional experience
Work history
Medicines Information Associate
medac Pharma
Stirling
12.2023 - Current
- Provided high-quality medicines information and customer care call handling service by answering telephone and email enquiries in an accurate, confident, and professional manner.
- Responded to enquiries about the medicinal products from HCPs, customers, patients, and members of the public in compliance with the applicable regulations and industry standards (ABPI, MHRA Blue Guide, etc) and internal SOPs.
- Identified and dealt with complex medicines information enquiries, adverse event cases and product quality complaints.
- Managed documentation for a manual electronic Quality Management System (QMS).
- Authored, reviewed, and revised internal SOPs to support quality management and operational efficiency.
- Conducted internal audits to ensure consistent regulatory adherence.
- Developed corrective action plans and preventative measures addressing non-compliance findings from audit results effectively.
- Collaborated with cross-functional teams to streamline successful product launches.
Medical receptionist
SSP Health
Bolton
10.2023 - 12.2023
- Kept organised documentation for multiple GP practices.
- Managed high-volume phone calls, resulting in efficient appointment setting.
- Provided empathetic customer service during stressful medical situations; eased patient anxiety.
- Protected patient rights through continued discretion and confidentiality.
- Collected and provided patient information to relevant medical professionals.
- Managed digital and manual filing systems.
Pharmacovigilance Specialist
ProPharma Group
Richmond, North Yorkshire
10.2021 - 12.2022
- Managed pharmacovigilance cases through documentation and case processing.
- Performed case processing of adverse events via data entry of SAEs into Argus safety database, conducted follow-up, and wrote accurate and complete case narratives in accordance with internal guidelines, SOPs, and US/UK safety regulations.
- Trained and mentored other junior PV specialists and developed training materials and training presentations for pharmacovigilance associates.
Education
Postgraduate certificate - Drug Discovery, Development and Delivery
Liverpool John Moores University
Liverpool, LIV09.2021
Bachelor of Science - Pharmaceutical Science
Liverpool John Moores University
Liverpool, LIV2020
Skills
- Excellent verbal, written, and interpersonal communication skills
- Proficient with Microsoft Office Suite (Outlook, Word, Excel)
- Able to work independently and collaboratively in a multidisciplinary team
- Flexibility to adapt and meet fluctuating business priorities
- Ability to interpret and present complex clinical data clearly to a variety of audiences
- Experience in Regulatory Compliance and Document Management of electronic Quality Management System (QMS)
- Experience in working with safety databases (Argus) and medical coding of adverse events and diseases (MedDRA)
Timeline
Medicines Information Associate
medac Pharma
12.2023 - Current
Medical receptionist
SSP Health
10.2023 - 12.2023
Pharmacovigilance Specialist
ProPharma Group
10.2021 - 12.2022
Postgraduate certificate - Drug Discovery, Development and Delivery
Liverpool John Moores University
Bachelor of Science - Pharmaceutical Science
Liverpool John Moores University
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