ProPharma

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. 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 Medical Information Specialist (MIS) 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. Essential Functions Include: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 Standard Operating Procedures (SOPs) and client Working Practices (WPs). Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs. 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. Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. 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 General Provides after-hours coverage on a rotated basis subject to business requirements. 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. Other activities as assigned as delegated by the Manager. Qualified Candidates Must Have Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree 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 the target language for the role English language proficiency. Japan-based roles only: TOEIC 800= Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards. Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability. Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills. Proactive with demonstrative ability to independently identify problems and suggest effective solutions. Ability to learn, take instruction and apply to daily operations/tasks. Receptive to constructive feedback and able to take responsibility for work allocated. Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects. Effectively work independently and as part of a team. 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 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.***

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. 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 Medical Information Specialist (MIS) 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. Essential Functions Include: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 Standard Operating Procedures (SOPs) and client Working Practices (WPs). Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs. 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. Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. 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 General Provides after-hours coverage on a rotated basis subject to business requirements. 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. Other activities as assigned as delegated by the Manager. Qualified Candidates Must Have Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree 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 the target language for the role English language proficiency. Japan-based roles only: TOEIC 800= Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards. Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability. Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills. Proactive with demonstrative ability to independently identify problems and suggest effective solutions. Ability to learn, take instruction and apply to daily operations/tasks. Receptive to constructive feedback and able to take responsibility for work allocated. Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects. Effectively work independently and as part of a team. 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 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.*** Show more Show less

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. 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. Essential Functions With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission‑level documents). Supervises, trains, and mentors less experienced medical writers, as necessary. Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates. Strives to complete medical writing deliverables on time and within budget. With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines. Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables. Coordinates QC reviews of documents and maintains audit trails of changes as applicable. Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency. If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output). Performs peer review of documents written by other medical writers, as required. Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings). Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing. Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership. Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team. Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team. Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). Other duties as assigned. Necessary Skills And Abilities Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information. Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines. Advanced understanding of regulatory submission requirements and processes. Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures. Exceptional project management skills and strong communication skills with a high attention to detail and quality. English language proficiency and familiarity with American Medical Association (AMA) style. Strong experience in relationship building and strategic collaboration on key business accounts. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables. Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Educational Requirements Bachelor’s degree or higher, preferably in medical or scientific discipline. Experience Requirements Minimum of 6 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case‑by‑case basis. 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.*** Show more Show less

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. 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 Medical Information Specialist (MIS) 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. Essential Functions Include: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 Standard Operating Procedures (SOPs) and client Working Practices (WPs). Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs. 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. Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. 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 General Provides after-hours coverage on a rotated basis subject to business requirements. 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. Other activities as assigned as delegated by the Manager. Qualified Candidates Must Have Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree 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 the target language for the role English language proficiency. Japan-based roles only: TOEIC 800= Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards. Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability. Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills. Proactive with demonstrative ability to independently identify problems and suggest effective solutions. Ability to learn, take instruction and apply to daily operations/tasks. Receptive to constructive feedback and able to take responsibility for work allocated. Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects. Effectively work independently and as part of a team. 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 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.*** Show more Show less

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. 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 Medical Information Writer role is responsible for writing technical responses such as letters or frequently asked questions (FAQs) to be used to answer enquiries received by Medical Information. This may involve updating existing responses or writing new standard responses. Production of other documents may be required. Essential Functions Include:Medical Information service delivery Extensive training, supervision, mentoring and advice will be provided to support the Medical Information Writer in the conduct of the designated responsibilities listed below: Carrying out comprehensive and accurate literature searches in Medline, or other databases as required, for technical medical information letters or documents. Preparing medical information letters and other documents using information gathered from literature searches or similar technical information. This may require condensing large amounts of technical data into concise and readable standard documents. Updating existing written documents, by checking the information within them is still accurate and up to date, and adding new information identified from literature searches in the most appropriate places to ensure readability and technical flow. Ensuring that all written items are accurate, readable and technically proficient and comply with ProPharma SOPs and the requirements of the client as defined in client specific Working Practices. Quality Assurance Quality checking own work and checking simple documents of others within the team under guidance to ensure standards are met and maintained. General Maintaining awareness of, and ensuring compliance with, the legal requirements and professional guidelines associated with the provision of medical information within the pharmaceutical and healthcare industries. Ensuring that the Confidentiality Statement within the Contract of Employment is adhered to at all times in respect of the data and property of ProPharma and its clients. Ensuring that any confidential information or personal data related to ProPharma, and its clients is managed in accordance with Data Privacy regulations as described in ProPharma Standard Operating Procedures (SOPs) Working in a professional manner at all times with clients, customers, team members and management. Other duties as assigned. Qualified Candidates Must Have A human life sciences degree. Excellent written communication skills Computer literacy. Sound planning, prioritising and organisational skills. Excellent accuracy and attention to detail. Able to work within a team in an open and professional manner. 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.*** Show more Show less

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. 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. Essential Functions Indepentendly performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Client’s disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills And Abilities Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency. Educational Requirements Minimum of bachelor’s degree in related field (scientific field preferred). Experience Requirements Minimum of 2+ years of direct experience in disclosures and/or data transparency. CRO or Outsourcing experience preferred. 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.*** Show more Show less

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. 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. Essential Functions Provide statistical programming and validation for life sciences-related projects including clinical trial datasets and tables, listings, and figures. Access and convert data to SAS datasets and other file types from database management system and PC file formats (e.g., Microsoft Excel, text files). Work with external vendors to develop and/or monitor the content and structure of SAS datasets and other files. Work closely with statisticians and other statistical programmers to generate and validate outputs to ensure accuracy and ensure the quality and soundness of statistical programming algorithms. Provide input to specifications of tabulation and analysis datasets, validation plans, and other related documents Other duties as assigned. Necessary Skills And Abilities In-depth knowledge of statistical programming. Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners. Ability to program in SAS and/or R preferred. Educational Requirements Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related discipline, or a combination of other education with 1+ years of relevant work experience. Experience Requirements Experience with CDISC data structures, such as SDTM and ADaM. 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.*** Show more Show less

We're hiring an Administrative Assistant with at least 2 years of relevant experience to support our clients in Australia and China. This is a full-time, remote position requiring availability during the Australian shift (5:00 AM – 2:00 PM IST) . What We’re Looking For: Strong communication skills—both verbal and written Immediate joiner preferred General Administration Responsibilities General administrative duties as delegated by the Manager. Answering the main telephone line into the Company in a professional manner and transferring calls as appropriate. On an ad-hoc basis providing reception cover which includes meetings, greeting, and signing in all visitors to the ProPharma Group office in a friendly, courteous and professional manner. Supporting the filing clerks including opening the daily mail received into the company, franking and posting the mail, filing, archiving and checking stationery stocks. Effectively perform in at least three of the following task areas: MI Correspondence Client Reports. AE/PQC/PE Receipting Article Delivery Service Data Documents Booking training Personal Training Records Travel & Accommodation Test Marking Quality Assurance Maintaining a good level of quality in all aspects of the job. Complying with the procedures documented in the Company Standard Operating Procedures (SOPs) and Working Instructions (WIs). General Having a solid working knowledge of, and to comply with, the Standard Operating Procedures of ProPharma Group. Working in a professional manner at all times, with clients, customers, team members, and management. Complying with the Company’s Health and Safety Policies. Ensuring the Confidentiality Statement within the Contract of Employment is always adhered to in respect of the data and property of ProPharma Group, its clients and employees of the business. Ensuring that any confidential information or personal data related to ProPharma Group and its clients is managed in accordance with Data Privacy regulations as described in ProPharma Group SOPs. Other duties as assigned Educational Requirements: Graduate with two years of relevant work experience Qualifications: Able to work within a team in a professional manner. Sound written and oral communication skills. Good accuracy and attention to detail skills. Solid level of productivity on all tasks. Sound organizational and prioritizing skills showing an effective workload management system. Able to understand and follow processes. Pleasant and professional telephone manner. Computer literacy (MS Office)

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. 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 Medical Information Admin Assistant provides comprehensive administrative support to the Medical Information (MI) Enquiry Handling teams and Senior Management in an accurate and efficient manner. Responsibilities General administrative duties as delegated by management. Answering the main telephone line of the Company in a professional manner and transferring calls as appropriate. On an ad-hoc basis providing reception cover which includes meeting, greeting, and signing in all visitors to the ProPharma office in a friendly, courteous, and professional manner. Supporting the filing clerks, including opening the daily mail received into the company, franking, and posting the mail, filing, archiving and checking stationery stocks. Effectively perform in at least three task areas. Quality Assurance Maintaining a good level of quality in all aspects of the job. Complying with the procedures documented in the Company Standard Operating Procedures (SOPs) and Working Instructions (WIs). General Having a solid working knowledge of, and complying with, the Standard Operating Procedures of ProPharma Working in a professional manner at all times, with clients, customers, team members and management. Complying with the Company’s Health and Safety Policies. Ensuring the Confidentiality Statement within the Contract of Employment is always adhered to in respect of the data and property of ProPharma, its clients and employees of the business. Ensuring that any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations as described in ProPharma SOPs. Other duties as assigned. Necessary Skills And Abilities Able to work within a team in a professional manner. Sound written and oral communication skills. Good accuracy and attention to detail skills. Solid level of productivity on all tasks. Sound organizational and prioritizing skills showing an effective workload management system. Able to understand and follow processes. Pleasant and professional telephone manner. Computer literacy (MS Office). 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.***

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. 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 Medical Information Specialist (MIS) 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. Essential Functions Include:Medical Information service delivery Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via 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 Standard Operating Procedures (SOPs) and client Working Practices (WPs). Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs. 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. Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. 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 General Provides after-hours coverage on a rotated basis subject to business requirements. 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. Other activities as assigned as delegated by the Manager. Qualified Candidates Must Have Healthcare Professional, such as Nursing degree (RN/BS/BA/MS) OR Pharmacy degree 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 the target language for the role English language proficiency. Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards. Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability. Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills. Proactive with demonstrative ability to independently identify problems and suggest effective solutions. Ability to learn, take instruction and apply to daily operations/tasks. Receptive to constructive feedback and able to take responsibility for work allocated. Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects. Effectively work independently and as part of a team. 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 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.***

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. 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 Document Specialist position is responsible for formatting, reviewing compiling, and processing regulatory documents (both Word and PDF) in support of electronic publishing activities with a focus on quality, accuracy, and efficiency providing publishing support to ProPharma clients. Essential Functions Directly supports electronic submission of regulatory documents / applications including IND, CTA, NDA, BLA, MAA, etc. through formatting, processing, and compilation of Word and PDF documents to the appropriate client specifications. Formats and reviews Word documents in preparation for publishing, in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. Performs document conversion to PDF, and formats and reviews PDF documents to specification (for eCTD compliance), including bookmarks, hyperlinks, keyword linking, document properties, etc., in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. Compiles regulatory documents / reports, gathering all required documents, within all established timelines. Publishes regulatory documents according to all relevant guidelines and specifications for eCTD submission, performing all relevant pre- and post-publishing quality review checks. Prepares and transfers final documents for publishing, supporting client and internal team during submission preparation, routing documents for review and approval, where applicable. Adheres to established regulatory standards / guidelines including but not limited to: ICH E3 / E6(R2) / M4, EU MDR / IVDR, Company standard operating procedures, and client standards instructions. Supports multiple publishing activities / projects simultaneously and manages own workload, ensuring completion of all projects within established timelines, immediately escalating any issues. Manages client expectations and interacts and communicates directly with clients to ensure accuracy and maintain timeline integrity. Performs peer / quality review of documents processed by other team members as requested. Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to document publishing. Brings issues and potential concerns to line manager / client oversight manager’s attention in a timely manner. Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). May occasionally be required to work outside of normal business hours to support client’s needs. Other duties as assigned. Necessary Skills And Abilities Extensive knowledge and mastery of Microsoft Word (advanced level formatting). Extensive knowledge and experience with Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems (e.g., ISI Toolbox, Core Dossier). Excellent problem-solving skills, including the ability to think outside the box. Ability to work on multiple projects at a time. Exceptional project management and communication skills with a high attention to detail and quality. English language proficiency. Ability to think proactively and take initiative, with a willingness to take on new challenges. Ability to work independently and contact management team proactively when additional support and resources are needed. Ability to work effectively in a collaborative team environment. Ability to work within established working hours. Demonstrates a growth mindset and positive outlook in all work activities. Educational Requirements Bachelor’s degree, preferably in life sciences (or related field). Experience Requirements Minimum 3 years of experience in document publishing and / or formatting. Pharmaceutical / biotech industry experience (specifically, INDs / CTAs, NDAs / BLAs / MAAs) preferred. Other professional and/or educational experience may contribute toward these minimum requirements, as determined on a case-by-case basis. 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.***

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. 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. Job Description The Medical Information Admin Assistant provides comprehensive administrative support to the Medical Information (MI) Enquiry Handling teams and Senior Management in an accurate and efficient manner. Responsibilities General administrative duties as delegated by management. Answering the main telephone line of the Company in a professional manner and transferring calls as appropriate. On an ad-hoc basis providing reception cover which includes meeting, greeting, and signing in all visitors to the ProPharma office in a friendly, courteous, and professional manner. Supporting the filing clerks, including opening the daily mail received into the company, franking, and posting the mail, filing, archiving and checking stationery stocks. Effectively perform in at least three task areas. Quality Assurance Maintaining a good level of quality in all aspects of the job. Complying with the procedures documented in the Company Standard Operating Procedures (SOPs) and Working Instructions (WIs). General Having a solid working knowledge of, and complying with, the Standard Operating Procedures of ProPharma Working in a professional manner at all times, with clients, customers, team members and management. Complying with the Company’s Health and Safety Policies. Ensuring the Confidentiality Statement within the Contract of Employment is always adhered to in respect of the data and property of ProPharma, its clients and employees of the business. Ensuring that any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations as described in ProPharma SOPs. Other duties as assigned. Necessary Skills And Abilities Able to work within a team in a professional manner. Sound written and oral communication skills. Good accuracy and attention to detail skills. Solid level of productivity on all tasks. Sound organizational and prioritizing skills showing an effective workload management system. Able to understand and follow processes. Pleasant and professional telephone manner. Computer literacy (MS Office). 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.***

The Human Resources Assistant position is responsible for supporting the provision of an efficient, customer focused and proactive operational HR service to staff at all levels throughout the employment life cycle by providing administrative support to the Human Resources Team. Essential Functions: Assists with the provision of quality, effective, comprehensive, and professional Human Resources administrative duties. Assists with the administration and maintenance of HR policies, programs, and procedures. Drafts necessary documents and forms to support policies and procedures. Regularly provides information to multiple departments. Maintains personnel files both electronic and paper. Administers any HR related documentation in line with all aspects of the HR function including but not limited to: HR Database Management, Attendance Management, Payroll, Performance Management, Policy Development, Recruitment, selection, and onboarding, Leavers Maternity, paternity, and parental leave. Responds to basic inquiries regarding policies, procedures, and programs, ensuring smooth communication and prompt resolution of all queries. As allowed by law, conducts background and reference checks per company (and at times client) requirements. Will collect and file job descriptions as appropriate. Updates onboarding systems and notifications. Assists with preparing employee separation notices and related documentation. Ensures that confidentiality and relevant data protection requirements are met at all times. Assists with conducting new employee orientations and other sessions as deemed appropriate in the area of employee relations. In some countries, coordinate requests sent to the HR Department inbox and signposting requests to relevant HR Department team members. Follows relevant applicable laws and regulations. Assists with employee engagement and recognition initiatives. Provides general administrative support to the Human Resources and at times, Talent Acquisition Departments. Fosters and maintains a positive and professional working relationship with all customers, including management staff, contract staff, permanent hires and clients. Other duties as assigned. Necessary Skills and Abilities: Thorough knowledge of Microsoft Word, Excel, and Outlook; knowledge of Visio and PowerPoint desired. Possess effective written and oral communication skills; ability to write, type, express or exchange ideas of technical nature by means of spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and translate those instructions into physical execution of tasks. Ability to work with minimum supervision. Must be flexible and able to deal quickly and appropriately with individual situations as they arise. · Excellent organizational skills. Strong customer service skills. · High level of accuracy and attention to detail required. High level of confidentiality required. Ability to develop a good working knowledge of, and comply with, the Standard Operating Procedures of the Company Educational Requirements: B.S./B.A. in Business Administration, Human Resources Management, or related field desired. Ideally CIPD Level 3 qualified or working towards this. 5 GCSEs or equivalent, including Grade A – C in both English and Mathematics.

The Quality Lead position at ProPharma involves driving positive change and process improvement in the assigned region. This role serves as an independent and objective entity, supporting various operational teams and performing quality activities as per ProPharma Group's Quality Policy and procedures. The Quality Lead is responsible for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Developing, managing, and executing quality management processes to ensure compliance with regulatory requirements is a key aspect of this role. Essential Functions: - Maintaining awareness of and ensuring adherence to applicable SOPs/controlled documents, regulations, guidelines, and client agreements. - Serving as a control point for SOPs/controlled documents and Quality Management System documents. - Contributing to the creation of controlled documents such as SOPs and Work Instructions. - Supporting the internal quality program including quality assurance and quality control. - Assisting in investigating service complaints and deviations, identifying root cause and CAPAs, and communicating these to the Managers. - Collaborating with Operational and Client Services Managers to support preparation for client audits and regulatory inspections. - Hosting client audits and regulatory inspections at ProPharma Group and acting as an SME for quality topics. - Developing responses to CAPAs arising from client audits and regulatory inspections, with support from Operations Managers, Client Services, and Global Quality, and tracking to completion and closure. - Participating in relevant client operational meetings as directed by Management. - Supporting the Quality Manager in the Regional Quality Committee and acting as a regional representative in the Global Quality Committee. - Proactively identifying improvement opportunities to support the development of ProPharma Group as a leading provider of outsourced global Medical Information solutions. - Identifying any issues that could potentially impact services and escalating areas of concern within the business to Management, with potential corrective actions. - Other responsibilities as assigned. Necessary Skills & Abilities: - Excellent attention to detail and focus on quality. - Strong verbal and written communication skills. - Excellent workload management skills. - Ability to prioritize workload and meet deadlines. - Excellent questioning and listening skills. - Capable of resolving conflict constructively. - Able to collaborate with colleagues in other departments effectively. - Ability to speak effectively in interpersonal situations and presentations. - Possesses a service-oriented approach. - Flexible and proactive toward changing needs. - Good understanding of quality assurance regulations and guidelines, preferably related to cGxP. - Quality Assurance experience in internal and external audits, maintaining regulated documents, and training files, preferably related to cGxP. - Knowledge of FDA regulations for adverse event and product complaint reporting. - Proficiency in MS Word, Excel, and PowerPoint. Educational Requirements: - University/Bachelor's degree and/or appropriate relevant work experience. Experience Required: - 5 years Quality experience in pharmaceutical or medical device industries or other regulated industry. - Previous experience in data mining, analysis, and presentation. - Previous audit experience preferred. ProPharma Group is committed to diversity, equity, and inclusion, creating a workplace where employees can be their authentic selves and are encouraged to be innovative and collaborative. As an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. Please note that ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Phone calls or emails regarding this posting are not accepted.,

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. 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. Job Summary The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company. Essential Functions Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities. Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Reconciliation of relevant process trackers. Extraction and validation of data (RSI, Sales, previous reports, RMP, signals). Generation of Line Listings (LL) from safety database Providing reliable support for high priority Ad-hoc activities. Necessary Skills And Abilities. Analytical and problem-solving skills. Sound organizational skills Able to work within a team in an open and professional manner Excellent attention to detail and focus on quality Understanding of ICH-GCP, FDA, EMA and other relevant Global regulations related to PV Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines. Awareness of global culture and willingness to work in a matrix environment Knowledge in other pharmacovigilance processes, ability to author/update SOPs or WIs, to identify and author deviations/CAPAs." Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Computer proficiency, IT skills, expertise and an ability to work with web based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Educational Requirements Bachelor/master’s degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience Experience Requirements 2+ years’ experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients Experience in literature screening activities and/or experiences in authoring and reviewing aggregate reports 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.***

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. 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. Job Summary The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company. Essential Functions Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities. Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Reconciliation of relevant process trackers. Extraction and validation of data (RSI, Sales, previous reports, RMP, signals). Generation of Line Listings (LL) from safety database Providing reliable support for high priority Ad-hoc activities. Necessary Skills And Abilities. Analytical and problem-solving skills. Sound organizational skills Able to work within a team in an open and professional manner Excellent attention to detail and focus on quality Understanding of ICH-GCP, FDA, EMA and other relevant Global regulations related to PV Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines. Awareness of global culture and willingness to work in a matrix environment Knowledge in other pharmacovigilance processes, ability to author/update SOPs or WIs, to identify and author deviations/CAPAs." Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Computer proficiency, IT skills, expertise and an ability to work with web based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Educational Requirements Bachelor/master’s degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience Experience Requirements 2+ years’ experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients Experience in literature screening activities and/or experiences in authoring and reviewing aggregate reports 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.***

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. 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. ProPharma is seeking an experienced Senior Medical Writer II to join our dynamic team in India. In this role, you will be responsible for authoring high-quality medical writing deliverables that demonstrate precision, clarity, and efficiency. As a key contributor, you will provide expert medical writing support to ProPharma’s global clients, ensuring that all documents meet the highest scientific and regulatory standards. This position offers the opportunity to collaborate with cross-functional teams, contribute to impactful healthcare solutions, and grow within a leading provider of regulatory, clinical, and medical information services worldwide. Essential Functions With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission‑level documents). Supervises, trains, and mentors less experienced medical writers, as necessary. Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates. Strives to complete medical writing deliverables on time and within budget. With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines. Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables. Coordinates QC reviews of documents and maintains audit trails of changes as applicable. Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency. If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output). Performs peer review of documents written by other medical writers, as required. Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings). Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing. Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership. Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team. Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team. Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). Necessary Skills & Requirements Bachelor’s degree or higher, in a medical or scientific discipline. Minimum of 6 years’ experience writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics within a CRO, pharmaceutical, or biotechnology environment. Proven expertise in authoring and editing a wide range of medical writing deliverables across clinical, safety, regulatory, and device/diagnostics documents. Strong knowledge of clinical research principles, phases, and therapeutic areas, with the ability to interpret and present complex clinical data. Advanced understanding of global regulatory guidelines, submission requirements, and processes (e.g., ICH E3/E6(R2), EU MDR/IVDR, FDA, EMA), with proficiency in applying SOPs, client standards, and templates. Exceptional project management, communication, and time-management skills, with high attention to detail and quality. Experience mentoring junior writers and building collaborative relationships with clients and cross-functional teams. Proactive, resourceful, and adaptable, with the ability to work independently while seeking support when needed. Requirements 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.***

For the past 20 years, ProPharma has been dedicated to enhancing the health and well-being of patients through the provision of expert advice and guidance that enables biotech, medical device, and pharmaceutical organizations of all sizes to confidently progress scientific innovations and introduce new therapies. ProPharma collaborates with its clients utilizing an advise-build-operate model throughout the entire product lifecycle. With profound expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers a comprehensive suite of customizable consulting solutions that mitigate risks and expedite the progression of partners" most prominent drug and device initiatives. The Pharmacovigilance (PV) Scientist plays a crucial role in supporting activities within the Benefit Risk group by ensuring the completion of day-to-day operational tasks. The PV Safety Scientist is expected to maintain professionalism and diligence, engage with the director and management team members within the group on any matters, and collaborate with senior PV Scientists. Additionally, the PV Safety Scientist is responsible for setting a positive example and ensuring that quality standards are consistently met within the organization. Essential Functions: - Authoring various Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ACO/DSUR) for submission to local and other Health Authorities. - Creating Risk Management Plans (RMPs) as part of routine Pharmacovigilance activities. - Drafting Signal Management Reports. - Conducting literature searches and validating content for the aggregate reports. - Reconciling relevant process trackers. - Extracting and validating data (RSI, Sales, previous reports, RMP, signals). - Generating Line Listings (LL) from the safety database. - Providing reliable support for high-priority Ad-hoc activities. Necessary Skills And Abilities: - Strong analytical and problem-solving skills. - Effective organizational skills. - Ability to work collaboratively within a team in a professional manner. - Exceptional attention to detail and focus on maintaining quality standards. - Proficiency in understanding ICH-GCP, FDA, EMA, and other relevant Global regulations related to PV. - Demonstrated capability to analyze and interpret large volumes of data concisely and scientifically, in compliance with regulatory deadlines. - Familiarity with global culture and willingness to operate within a matrix environment. - Proficiency in other pharmacovigilance processes, including the ability to author/update SOPs or WIs and identify and document deviations/CAPAs. - Ensuring that client deliverables adhere to relevant regulatory requirements and are delivered within agreed timelines. - Ability to summarize medical text and data concisely, accurately, and effectively, as well as write unambiguous medical content. - Proficiency in computer skills, IT applications, and working with web-based platforms, along with familiarity with the Windows Operating system and the MS Office suite (Word/Excel/PowerPoint). Educational Requirements: - Bachelor/masters degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience. Experience Requirements: - Minimum of 2 years of experience in Pharmacovigilance with a focus on medical writing, literature search, and/or signal detection. - Experience in contributing to the compilation of metrics and engaging in quality discussions internally and with clients. - Experience in literature screening activities and/or authoring and reviewing aggregate reports. ProPharma Group values diversity and strives to foster a workplace where individuals can be their authentic selves. The company is committed to promoting diversity, equity, and inclusion, encouraging employees to showcase their innovative, collaborative, and entrepreneurial talents. As an Equal Opportunity Employer, ProPharma Group provides a supportive environment where all employees are empowered to achieve success.,

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. 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. Job Summary The primary function of the Workforce Management Analyst will be to aid the Associate Director, Workforce Management and Insights with managing the Workforce Management platform and using Analytical tools to generate reporting within the Contact Center. Essential Functions Support in providing strategic leadership by sharing responsibility for overseeing the optimization of the organization's workforce including managing staffing levels, forecasting labor needs, scheduling employees efficiently, analyzing workforce data, and implementing strategies to maximize productivity and align staffing with business objectives. Collaborate with various departments to ensure efficient resource allocation and workforce planning aligned with company goals. Execute workforce management strategies, monitor performance metrics, and lead a team of workforce analysts to identify areas for improvement and drive continuous optimization across the organization. Execute comprehensive workforce plans, including forecasting labor demand, staffing level requirements, and talent acquisition strategies to meet business needs. Utilize data analytics to track key workforce metrics like productivity, absenteeism, overtime, and adherence to schedules to identify areas for improvement and make data-driven decisions. Assist with the development and implementation of automated scheduling systems to ensure efficient allocation of staff across shifts and departments, considering peak demand periods and employee availability. Necessary Skills And Abilities Partner with various departments including Business Development, QA, Operations, HR, and Finance to ensure alignment between workforce strategies and overall business objectives. Promote a positive work environment by considering employee preferences and work-life balance when developing scheduling strategies. Identify and implement process improvements to enhance workforce efficiency and productivity. Strong analytical skills with proficiency in data analysis and reporting software. Creative thinking. Ability to interpret data and provide recommendations to create efficiencies, cost savings, and help contribute to generating revenue. Expertise in workforce management systems and principles. Proficiency in data visualizations, dashboard creation via Power BI/Tableau, advanced Excel functions. Utilize Power BI/Tableau and Excel to collect and synthesize data to assist in decision making. Ability to work efficiently with high attention to detail while meeting multiple concurrent deadlines. Excellent communication and collaboration skills to work effectively with cross-functional teams. Proven ability to develop and execute strategic workforce plans. Strong problem-solving and decision-making skills. Educational Requirements Bachelor’s degree in business preferred or equivalent experience. Experience Requirements 3+ years of relevant experience working in a contact center in a leadership, reporting, analytics, or WFM role. 3+ years of experience working with WFM software platforms 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.***

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. 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. THIS ROLE IS BASED IN BANGALORE The Pharmacovigilance (PV) Specialist, Case Processing manages individual case safety reports, performs initial case-level assessment of expectedness, confirms seriousness, composes accurate and thorough medical narratives, and generates queries for missing or unclear information. The 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 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 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 as needed. Other duties as assigned Necessary Skills And Abilities Strong verbal, written and interpersonal communication 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. Basic knowledge of Pharmacovigilance. Educational Requirements Required: a Bachelor's degree in life sciences. Preferred: advanced degree, RN, RPh, PharmD or equivalent. Experience Requirements Two 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.***