Jobs · Quality Assurance

PV Auditor - Freelance Position

ADAMAS Consulting · Raleigh, NC · 1 mo ago
RemoteRemoteQuality AssuranceFull-time
We need to output HTML fragment with sections only if real content. No job title heading. Use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to parse the posting. Company Description: "Medicine moves forward... That's company description; maybe we can put under "About the role"? Actually "About the role" is typical heading for role description. We have "Job Description" section: ADAMAS Consulting is looking for PV Auditor on a freelance basis to cover audits across USA and Canada. Both full and part time (0.6+ FTE) will be considered Planning, preparation, conduct, reporting and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines Executing audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP) Performing GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry. That's responsibilities. Qualifications: Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders Expert knowledge of national and international Pharmacovigilance legislation and guidelines Proficient in managing projects and ensuring deliverables are provided timeously Ability to identify issues and offer solutions in a pragmatic way Bachelor’s Degree in Life Sciences preferred Up to 40% travel and ability to conduct remote audits Additional Information: When you join Ergomed Group... values etc. That's more about company culture/benefits? Could be "Benefits" but not explicit benefits like health insurance. It's more about values and collaborative environment. Could be "About the company" but we only have allowed headings. We could put under "About the role"? Might be better to put under "About the role" as description of company and role. However we already have job description content. Could create "About the role" with company description and additional info. But we must not repeat job title as heading. Use headings only when there is real specific content. We have content for Responsibilities (Job Description). Qualifications. Possibly Skills? Not explicit separate skills list; qualifications cover skills. Could combine Qualifications and Skills? But we need to follow allowed headings; we can include Qualifications heading and list items. Skills heading maybe not needed if no distinct skills beyond qualifications. Benefits: The posting mentions values, collaborative environment, professional growth, etc. Could be considered benefits but not explicit like health insurance, PTO. The instruction: never create Benefits section unless posting actually states them. It does state "We have built a supportive, collaborative environment where professional growth is encouraged..." That's a benefit of working there. Could be considered Benefits. However it's vague but still substantive. I'd include a Benefits section with those points. Pay and Schedule: Not specified (only mention freelance basis, full/part time 0.6+ FTE considered). That's schedule info: both full and part time (0.6+ FTE) will be considered. That's schedule info. So we can include Schedule heading with that detail. Pay: not specified, so we should NOT create Pay section. Thus sections: About the role (maybe company description + role overview), Responsibilities, Qualifications, Benefits, Schedule. We need to use

for each heading. Use
  • for any list of duties/requirements/benefits. Use

    for prose. We must preserve all substantive information; do not invent or summarize away detail. So we need to include all details. Let's extract content: Company Description paragraph: "Medicine moves forward here. So will you. ADAMAS Consulting helps the world's pharmaceutical and biotechnology companies uphold the highest standards of quality, compliance and patient safety. Since 2007 we have partnered with organizations across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is intelligence: helping clients see the compliance risks that matter most and prevent the problems that could put patients at risk. That takes sharp, independent thinking and deep expertise, which is exactly what our people bring. Here your knowledge is valued and shared, not kept in silos. We have built a supportive, collaborative environment where professional growth is encouraged and where you can make a real impact across the industry, working alongside some of the most respected companies in the field." Job Description: "ADAMAS Consulting is looking for PV Auditor on a freelance basis to cover audits across USA and Canada. Both full and part time (0.6+ FTE) will be considered Planning, preparation, conduct, reporting and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines Executing audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP) Performing GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry." Note there is missing punctuation; we keep as is. Qualifications bullet list: - Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders - Expert knowledge of national and international Pharmacovigilance legislation and guidelines - Proficient in managing projects and ensuring deliverables are provided timeously - Ability to identify issues and offer solutions in a pragmatic way - Bachelor’s Degree in Life Sciences preferred - Up to 40% travel and ability to conduct remote audits Additional Information (values): "When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting. We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. Quality: we hold ourselves to the standard patients deserve. Integrity and trust: we do the right thing, especially when it is hard. Drive and passion: we care about the outcome, because someone is waiting on it. Agility and responsiveness: we move quickly, because patients cannot wait. Belonging: everyone is welcome, and every voice counts. Collaborative partnerships: we go further by going together. We look forward to welcoming your application." We can turn values into list items. Schedule: "Both full and part time (0.6+ FTE) will be considered" (already in job description). Could also mention freelance basis, cover audits across USA and Canada. That's location/schedule? Might be location. But schedule heading: we can include that line. We need to avoid duplication: The job description already includes the schedule line; we might not repeat it. But we need to include schedule info somewhere. Could put schedule section with that line. We must not repeat job title as heading. No job ID. We must remove boilerplate: cookie/navigation/legal/EEO etc. Not present. Now craft HTML. Structure:

    About the role

    Company description paragraph(s). Maybe also short role overview? Could combine company description and role overview. But we have separate job description; maybe About the role includes company description and brief role summary (freelance PV Auditor). However we already have responsibilities separate. To avoid duplication, we can put company description in About the role, and responsibilities separate. Thus About the role: company description paragraph. Responsibilities: list of duties from job description (excluding schedule line maybe). But job description includes planning..., executing..., performing... We'll list those. Qualifications: list. Benefits: list of values and supportive environment etc. Schedule: line about full/part time 0.6+ FTE and freelance basis, location USA/Canada. We need to ensure we preserve all substantive information: include freelance basis, cover audits across USA and Canada. Let's extract schedule info: "ADAMAS Consulting is looking for PV Auditor on a freelance basis to cover audits across USA and Canada. Both full and part time (0.6+ FTE) will be considered". We'll put that in Schedule section. Now ensure we don't repeat content: The responsibilities section should not include that sentence. So responsibilities: "Planning, preparation, conduct, reporting and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines", "Executing audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP)", "Performing GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry." Now Benefits: include supportive collaborative environment, professional growth encouraged, real impact, working alongside respected companies, values list, making difference, passionate collaborative team, diversity, values, etc. We'll list as bullet points. Now craft HTML. We need to use

    • for any list. For prose, use

      . Thus:

      About the role

      Medicine moves forward here. So will you. ADAMAS Consulting helps the world's pharmaceutical and biotechnology companies uphold the highest standards of quality, compliance and patient safety. Since 2007 we have partnered with organizations across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is intelligence: helping clients see the compliance risks that matter most and prevent the problems that could put patients at risk. That takes sharp, independent thinking and deep expertise, which is exactly what our people bring. Here your knowledge is valued and shared, not kept in silos. We have built a supportive, collaborative environment where professional growth is encouraged and where you can make a real impact across the industry, working alongside some of the most respected companies in the field.

      Responsibilities

      • Planning, preparation, conduct, reporting and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines
      • Executing audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP)
      • Performing GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry

      Qualifications

      • Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders
      • Expert knowledge of national and international Pharmacovigilance legislation and guidelines
      • Proficient in managing projects and ensuring deliverables are provided timeously
      • Ability to identify issues and offer solutions in a pragmatic way
      • Bachelor’s Degree in Life Sciences preferred
      • Up to 40% travel and ability to conduct remote audits

      Benefits

      • Supportive, collaborative environment where professional growth is encouraged
      • Opportunity to make a real impact across the industry
      • Work alongside some of the most respected companies in the field
      • Join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting
      • Diverse team united by shared values
      • Quality: hold ourselves to the standard patients deserve
      • Integrity and trust: do the right thing, especially when it is hard
      • Drive and passion: care about the outcome, because someone is waiting on it
      • Agility and responsiveness: move quickly, because patients cannot wait
      • Belonging: everyone is welcome, and every voice counts
      • Collaborative partnerships: go further by going together

      Schedule

      Freelance basis

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