Pharmacovigilance Medical Writing Scientist

3 weeks ago

United Kingdom ProPharma Full time

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Multilingual Medical Information Specialist (MMIS) position is part of the ProPharma Medical Information Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints

Medical Information service delivery

Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via telephone, website/e-mail, letter, fax, and scientific meetings on behalf of ProPharma` s pharmaceutical clients.
Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma internal policies and practices.
Accurately identifies, documents and reports adverse events, pregnancy reports, special situation events and product complaints in a clear and concise manner per government regulations, ProPharma`s Standard Operating Procedures (SOPs) and client Working Practices (WPs).
Translating English documents into the target language or vice versa and delivering these translated responses either on the phone or in writing.
Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data. Assists with writing custom medical information responses utilizing this data.
Quality Assurance
Maintains quality in all areas of the job, including performing quality checks on Adverse Events, Product Quality Complaints, correspondence, and enquiries logged into the Inquiry Handling Systems
Quality checking translations in line with the translation SOP. Adheres to company and country-specific privacy policies, ensuring any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations described in ProPharma SOPs and the Confidentiality Statement within the Contract of Employment.
Complies with the Company’s health and safety policies.
Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree
Fluency to mother tongue level in Portuguese
Fluent in English.
Excellent verbal and written communication skills, including proofreading, professional telephone etiquette and empathetic customer service skills.
Ability to write in a fluent and grammatically correct manner in Portuguese
Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards.
Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills.
Willingness to seek out additional workload projects.
Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database.

We are committed to diversity, equity, and inclusion. Please, no phone calls or emails to anyone regarding this posting.***

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