Job Description
ProPharma
Senior PV Specialist (legal/medical review)
ProPharma • United Kingdom • via LinkedIn
12 days ago
Full–time
Apply on LinkedIn
Job description
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 Senior Pharmacovigilance (PV) Specialist, Case Processing is primarily responsible for peer review of cases within the Case Processing team. The Senior PV Specialist performs initial case-level assessment of expectedness, confirms seriousness, performs quality check of individual case safety reports, composes accurate and thorough medical narratives, and generates queries for missing or unclear information. The Senior PV Specialist ensures all cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines, Working Practices, SOPs, and applicable safety regulations. The Senior PV Specialist maintains distinctive quality and commitment as the operating philosophy in carrying out all processes and continually seeks out ways to enhance customer service experience both internally and externally.
Essential Functions
• Responsible for overseeing and performing daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.
• Perform case follow up activities such as identification of information to be collected during follow-up.
• Creating and reviewing case narratives.
• Providing client notifications as required for case management.
• Supporting and contributing to the development of training materials and training delivery.
• Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs.
• Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
• Peer reviews of cases for quality, consistency, and accuracy.
• Provide oversight and direction of PV deliverables as a PV subject matter expert as needed.
• Perform Health Care Professional (HCP) review (as required).
• Mentors and trains less experienced staff.
• Other duties as assigned.
Necessary Skills And Abilities
• Strong verbal, written and interpersonal communication skills.
• Intermediate project management skills.
• High level of accuracy and attention to detail.
• Ability to identify and resolve problems in a timely manner.
• Able to work independently and collaboratively in a multi-disciplinary team.
• Excellent organization and prioritization skills; able to multitask.
• Intermediate knowledge of Pharmacovigilance.
• Working knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases.
• Legal/Medical case review experience preferred.
Educational Requirements
• Required: a Bachelor's degree in life sciences.
• Preferred: an advanced degree, RN, RPh, PharmD or equivalent.
Experience Requirements
Three years of related work experience.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
Report this listing
More jobs at ProPharma
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The Elite Job
Typing Jobs for Computer Operators (Remote Part-Time Job)
The Elite Job • India • via The Elite Job
2 hours ago
$20–$30 an hour
Full–time and Part-time
No Degree Mentioned
Apply directly on The Elite Job
Job description
Job Summary
The Elite Job is seeking detail-oriented and self-motivated individuals to join our team as Remote Computer Operators. This part-time role offers flexible working hours, enabling you to work from the comfort of your home. As a Computer Operator, you will be responsible for efficiently typing and managing digital content while meeting deadlines with accuracy and precision. This is an ideal opportunity for students, freelancers, or professionals seeking additional income.
Key Responsibilities
• Perform accurate typing tasks, including data entry and document formatting.
• Review and correct errors to ensure high-quality output.
• Maintain confidentiality and handle sensitive information responsibly.
• Manage and organize files digitally to ensure easy retrieval.
• Adhere to project guidelines and meet established deadlines.
• Communicate effectively with team leads regarding progress or issues.
• Required Skills and Qualifications
• Proficiency in typing with a speed of at least 40 words per minute (WPM).
• Strong attention to detail and accuracy in data handling.
• Familiarity with MS Office Suite (Word, Excel) and typing software.
• Basic knowledge of file management and online tools.
• Good written and verbal communication skills in English.
• Self-motivation and ability to work independently with minimal supervision.
• Experience
• Prior experience in typing, data entry, or related roles is preferred but not mandatory.
• Freshers with strong typing skills are welcome to apply.
• Working Hours
• Flexible part-time schedule of 3 5 hours per day.
• Choose shifts based on your availability.
• Knowledge, Skills, and Abilities
• Knowledge of basic computer operations and troubleshooting.
• Ability to prioritize tasks and manage time effectively.
• Problem-solving skills and adaptability in a remote work environment.
• Benefits
• Competitive pay based on performance and output.
• Work from the comfort of your home.
• Opportunity to develop and enhance typing and organizational skills.
• Part-time hours allow for work-life balance or additional income.
• Supportive and collaborative virtual team environment.
• Why Join
At The Elite Job, we prioritize flexibility, inclusivity, and career growth. By joining our team, you will become part of a company that values your contributions and provides a supportive platform to grow your skills. Whether you are looking to gain experience or earn a stable part-time income, this role offers a fulfilling opportunity tailored to your needs.
How to Apply
Interested candidates are invited to apply by submitting their updated resumes along with a brief cover letter highlighting their typing skills and relevant experience. Applications can be sent directly to us. Shortlisted candidates will be contacted for a typing assessment and virtual interview.
Senior PV Specialist (legal/medical review)
ProPharma • United Kingdom • via LinkedIn
12 days ago
Full–time
Apply on LinkedIn
Job description
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 Senior Pharmacovigilance (PV) Specialist, Case Processing is primarily responsible for peer review of cases within the Case Processing team. The Senior PV Specialist performs initial case-level assessment of expectedness, confirms seriousness, performs quality check of individual case safety reports, composes accurate and thorough medical narratives, and generates queries for missing or unclear information. The Senior PV Specialist ensures all cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines, Working Practices, SOPs, and applicable safety regulations. The Senior PV Specialist maintains distinctive quality and commitment as the operating philosophy in carrying out all processes and continually seeks out ways to enhance customer service experience both internally and externally.
Essential Functions
• Responsible for overseeing and performing daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.
• Perform case follow up activities such as identification of information to be collected during follow-up.
• Creating and reviewing case narratives.
• Providing client notifications as required for case management.
• Supporting and contributing to the development of training materials and training delivery.
• Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs.
• Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
• Peer reviews of cases for quality, consistency, and accuracy.
• Provide oversight and direction of PV deliverables as a PV subject matter expert as needed.
• Perform Health Care Professional (HCP) review (as required).
• Mentors and trains less experienced staff.
• Other duties as assigned.
Necessary Skills And Abilities
• Strong verbal, written and interpersonal communication skills.
• Intermediate project management skills.
• High level of accuracy and attention to detail.
• Ability to identify and resolve problems in a timely manner.
• Able to work independently and collaboratively in a multi-disciplinary team.
• Excellent organization and prioritization skills; able to multitask.
• Intermediate knowledge of Pharmacovigilance.
• Working knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases.
• Legal/Medical case review experience preferred.
Educational Requirements
• Required: a Bachelor's degree in life sciences.
• Preferred: an advanced degree, RN, RPh, PharmD or equivalent.
Experience Requirements
Three years of related work experience.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
Report this listing
More jobs at ProPharma
See web results for ProPharma
T
The Elite Job
Typing Jobs for Computer Operators (Remote Part-Time Job)
The Elite Job • India • via The Elite Job
2 hours ago
$20–$30 an hour
Full–time and Part-time
No Degree Mentioned
Apply directly on The Elite Job
Job description
Job Summary
The Elite Job is seeking detail-oriented and self-motivated individuals to join our team as Remote Computer Operators. This part-time role offers flexible working hours, enabling you to work from the comfort of your home. As a Computer Operator, you will be responsible for efficiently typing and managing digital content while meeting deadlines with accuracy and precision. This is an ideal opportunity for students, freelancers, or professionals seeking additional income.
Key Responsibilities
• Perform accurate typing tasks, including data entry and document formatting.
• Review and correct errors to ensure high-quality output.
• Maintain confidentiality and handle sensitive information responsibly.
• Manage and organize files digitally to ensure easy retrieval.
• Adhere to project guidelines and meet established deadlines.
• Communicate effectively with team leads regarding progress or issues.
• Required Skills and Qualifications
• Proficiency in typing with a speed of at least 40 words per minute (WPM).
• Strong attention to detail and accuracy in data handling.
• Familiarity with MS Office Suite (Word, Excel) and typing software.
• Basic knowledge of file management and online tools.
• Good written and verbal communication skills in English.
• Self-motivation and ability to work independently with minimal supervision.
• Experience
• Prior experience in typing, data entry, or related roles is preferred but not mandatory.
• Freshers with strong typing skills are welcome to apply.
• Working Hours
• Flexible part-time schedule of 3 5 hours per day.
• Choose shifts based on your availability.
• Knowledge, Skills, and Abilities
• Knowledge of basic computer operations and troubleshooting.
• Ability to prioritize tasks and manage time effectively.
• Problem-solving skills and adaptability in a remote work environment.
• Benefits
• Competitive pay based on performance and output.
• Work from the comfort of your home.
• Opportunity to develop and enhance typing and organizational skills.
• Part-time hours allow for work-life balance or additional income.
• Supportive and collaborative virtual team environment.
• Why Join
At The Elite Job, we prioritize flexibility, inclusivity, and career growth. By joining our team, you will become part of a company that values your contributions and provides a supportive platform to grow your skills. Whether you are looking to gain experience or earn a stable part-time income, this role offers a fulfilling opportunity tailored to your needs.
How to Apply
Interested candidates are invited to apply by submitting their updated resumes along with a brief cover letter highlighting their typing skills and relevant experience. Applications can be sent directly to us. Shortlisted candidates will be contacted for a typing assessment and virtual interview.
💡 Quick Summary
Seeking a career-building opportunity? The Typing Jobs for Computer Operators (Remote Part-Time Job) position is now open for candidates interested in the Work from home Jobs sector. This role in Barton offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Work from home Jobs is a plus.