Drug Safety Associate II

We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use

• for any list of duties/requirements/benefits, and

  for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, etc. Preserve all substantive info. Include a section only when posting has real, specific content for it. No filler like "commensurate with experience". Pay and Benefits sections only if posting actually states them. It does: Pay And Benefits section with pay range and benefits list. So include Pay and Benefits sections? The instruction: Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have separate Pay and Benefits headings, or combine? It says use those headings as examples; we can decide. Probably separate Pay and Benefits sections. Also Schedule: posting mentions remote position based on Pacific Time (PST) hours; that's schedule info. So include Schedule section. We need to extract responsibilities list, essential skills list, additional skills & qualifications list, work environment description, job type & location, pay and benefits, workplace type, application deadline? Application instructions should be removed. So we drop Application Deadline and any application instructions. Also drop About Actalent and EEO etc. Also drop "Work Environment" maybe we can incorporate into a section like Work Environment? Not in list of headings but we could treat as "About the role" or "Work Environment". The instruction says use headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we should map content to those headings. "About the role" could be the job description paragraph at start. Responsibilities list. Requirements could be essential skills? Qualifications maybe education? Skills maybe essential skills? Might be overlapping. We need to decide a sensible mapping. We have: Job Description paragraph (first). Then Responsibilities (list). Then Essential Skills (list). Then Additional Skills & Qualifications (list). Then Work Environment (paragraph). Then Job Type & Location (sentence). Then Pay And Benefits (pay range + benefits list). Then Workplace Type (sentence). Then Application Deadline (remove). Then About Actalent etc (remove). Also there is "Job Type & Location This is a Contract position based out of Alameda, CA." That's location and contract type. We need to avoid repeating job title as heading. So no

  Drug Safety Associate II

  . We need to output only HTML fragment. Let's craft sections:

  About the role

  The Drug Safety Associate II provides expert support in drug safety and pharmacovigilance, with a primary focus on the accurate and timely documentation of serious adverse events (SAEs) and other safety data. This role manages end-to-end case processing in the Argus Safety Database, ensures compliance with global clinical safety regulations and internal procedures, and contributes to the high-quality utilization of safety data across clinical and post-marketing programs.

  Responsibilities

  • Process and assess serious adverse events (SAEs) from initial receipt through case closure in the Argus Safety Database, ensuring complete and compliant documentation.
  • Perform end-to-end pharmacovigilance case processing, including case intake, medical assessment, coding, narrative writing, follow-up activities, expedited reporting, and quality control review for both clinical trial and post-marketing safety cases.
  • Generate queries and draft clear, medically sound case narratives and adverse event summaries to support robust safety evaluations.
  • Apply accurate and consistent coding of SAEs and AEs as reported in source documents, using established coding conventions to ensure standardized data categorization.
  • Contribute to the development and revision of coding conventions to support consistent and high-quality safety data across studies and products.
  • Define and apply a high standard of case quality review, ensuring sound medical safety data documentation in collaboration with the Drug Safety Physician.
  • Schedule and manage submissions of expedited safety reports in Argus in accordance with regulatory timelines and internal procedures.
  • Collaborate closely with cross-functional departments such as Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management to ensure appropriate collection, reconciliation, and handling of safety data.
  • Support continuous improvement of drug safety case processing workflows and procedures to enhance efficiency, quality, and regulatory compliance.
  • Perform additional drug safety and pharmacovigilance duties as assigned to support departmental goals and regulatory commitments.
  Now we need Requirements, Qualifications, Skills sections. The posting has Essential Skills (list) and Additional Skills & Qualifications (list). Also education requirement: Bachelor’s degree (BS/BA) in a related discipline with at least 5 years of related industry experience, or a master’s degree (MS/MA) in a related discipline with at least 3 years of related experience, or a PhD in a related discipline. Alternatively, BS or MS in Nursing, Pharmacy, or another clinical degree with a minimum of 3–5 years of clinical experience. We could put education under Qualifications. Essential Skills could be Skills. Additional Skills & Qualifications could be Requirements? Or we could combine. Let's decide:

  Qualifications

  Bachelor’s degree (BS/BA) in a related discipline with at least 5 years of related industry experience, or a master’s degree (MS/MA) in a related discipline with at least 3 years of related experience, or a PhD in a related discipline. Alternatively, BS or MS in Nursing, Pharmacy, or another clinical degree with a minimum of 3–5 years of clinical experience.

  Skills

  • Minimum 3 years of recent, hands-on experience with the Argus Safety Database, including end-to-end pharmacovigilance case processing, case management, and quality control review.
  • Demonstrated end-to-end pharmacovigilance case processing experience covering case intake, assessment, coding, narrative writing, follow-up, expedited reporting, and QC review for clinical and post-marketing cases.
  • Minimum 5 years of pharmacovigilance experience within a biotech, pharmaceutical, or contract research organization (CRO) environment.
  • Strong understanding of global clinical safety and pharmacovigilance regulations and guidelines.
  • Proficiency in medical documentation, including clear and accurate narrative and adverse event summary writing.
  • Ability to perform detailed case quality reviews and ensure complete, accurate, and compliant safety case documentation.
  • Experience collaborating with cross-functional teams involved in clinical development, operations, data management, regulatory affairs, and project management.

  Requirements

  • Experience in drug safety and pharmacovigilance, with experience handling both clinical trial and post-marketing safety data.
  • Familiarity with safety databases and case processing workflows, particularly Argus.
  • Ability to interpret medical and clinical information from source documents and translate it into structured safety case data.
  • Strong attention to detail and commitment to data accuracy and regulatory compliance.
  • Effective written and verbal communication skills for cross-functional collaboration.
  • Organizational skills to manage multiple cases, timelines, and expedited reporting requirements.
  • Comfort working in a regulated environment with established standard operating procedures and quality standards.
  Now Work Environment: we could put under About the role? But we have a separate section maybe "Work Environment" not in list but we could incorporate into About the role or maybe "About the role" already covers. However we have a paragraph about Work Environment: "This is a remote position based on Pacific Time (PST) hours. The role operates in a structured, compliance-driven pharmacovigilance environment, working extensively with the Argus Safety Database and other clinical and regulatory systems. Collaboration with cross-functional teams occurs virtually, requiring reliable connectivity and the ability to work effectively in a remote setting while aligning with PST business hours." We could put that under a heading "Work Environment" but not in the prescribed list. The instruction says use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It implies we should use those headings for sections. It doesn't say we cannot add others, but better to stick to those. We could incorporate Work Environment content into About the role or Schedule. Since Schedule section is about PST hours, we can put schedule info there. Work environment details about remote, structured environment could go under About the role maybe. Let's add Schedule section: includes remote position based on Pacific Time (PST) hours, need reliable connectivity, ability to work effectively remote aligning with PST business hours.

  Schedule

  This is a remote position based on Pacific Time (PST) hours. Collaboration with cross-functional teams occurs virtually, requiring reliable connectivity and the ability to work effectively in a remote setting while aligning with PST business hours.

  Now Job Type & Location: "This is a Contract position based out of Alameda, CA." Could be part of About the role or maybe we add a section "Job Type & Location" but not in list. Could incorporate into About the role or maybe we add a heading "Job Type & Location" but not in list. The instruction says use those headings as examples; we could still add others but better to avoid. We could put location info in About the role paragraph. Let's adjust About the role to include location and contract type. So About the role paragraph: "The Drug Safety Associate II provides expert support... This is a Contract position based out of Alameda, CA." plus remote schedule? Actually schedule separate. Now Pay and Benefits: we need separate Pay and Benefits sections? The instruction lists Benefits and Pay as separate possible headings. We'll create both. Pay section: include pay range. Benefits section: list benefits. Let's extract benefits list: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave). We'll put each as
• . Now Workplace Type: "This is a fully remote position." Could be part of Schedule or About the role. Since we already have Schedule about remote PST hours, we could mention fully remote there. But we have Schedule already about remote PST hours; we can add that it's fully remote. Let's adjust Schedule paragraph: "This is a fully remote position based on Pacific Time (PST) hours. Collaboration with cross-functional teams occurs virtually, requiring reliable connectivity and the ability to work effectively in a remote setting while aligning with PST business hours." Now we have all sections. Check for any boilerplate removed: We removed About Actalent, EEO, legal, accommodation, AI, etc. Also removed Application Deadline. Also removed "Job Type & Location" as separate heading but we incorporated location into About the role. Now ensure no repeated job title as heading. No. Check for any filler like "commensurate with experience" - none. Now output HTML fragment. Let's craft final HTML:

  About the role

  The Drug Safety Associate II provides expert support in drug safety and pharmacovigilance, with a primary focus on the accurate and timely documentation of serious adverse events (SAEs) and other