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Collections Representative – Us Health Care/Rcm/Ar Calling – Chennai

1+ years
Not Disclosed
20 July 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Medical Writer – Pharmacovigilance & Signal Management

Location: India (Remote | Hyderabad | Bengaluru)
Company: Parexel
Work Mode: Remote / Hybrid (India-based)
Compensation / Salary: Not disclosed (competitive as per industry standards)


Job Summary (Pharma / PV focused)

Parexel is hiring a Senior Medical Writer to lead signal detection, signal evaluation, and end‑to‑end safety medical writing across early and late-phase clinical development and post‑marketing portfolios. You will author SERs, validation reports, health authority responses, and provide strategic input on benefit–risk assessments, regulatory submissions, and risk management—ensuring compliance with ICH-GVP, FDA, EMA, and global pharmacovigilance (PV) expectations.


Key Responsibilities

  • Lead signal detection, tracking, assessment, and documentation (qualitative & quantitative) from multiple data sources (regulatory databases, sponsor DBs, literature, HA sites).

  • Author and review Signal Evaluation Reports (SERs), validation reports, HA responses, and other safety documents.

  • Provide safety input to new drug applications, regulatory filings, and benefit–risk assessments.

  • Maintain expert knowledge of product safety profiles, labeling, SOPs, and global PV regulations.

  • Support clinical narratives and cross-functional safety deliverables.

  • Conduct and deliver internal safety trainings; mentor junior team members.

  • Ensure compliance with global reporting timelines and inspection readiness.


Required Skills & Qualifications

  • Degree in Life Sciences / Health / Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).

    • Degrees in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing with hospital exposure are an advantage.

  • Relevant experience in Medical Writing / Pharmacovigilance / Regulatory (Senior level role – preferably 4–6+ years).

  • Hands-on expertise with:

    • Signal detection & management (end-to-end)

    • SERs, PSUR/PBRER, RMPs, HA responses

    • Benefit–risk evaluation & safety surveillance

  • Strong command of ICH, GVP, FDA/EMA guidance.

  • Excellent analytical, writing, QC, and stakeholder communication skills.

  • Advanced MS Office & ability to work with web-based PV tools and databases.


Nice-to-Have (Boosters)

  • Experience with post-marketing safety & regulatory inspections.

  • Prior authorship of narratives, DSURs, PADERs, PSURs, PBRERs.

  • Familiarity with epidemiology, real-world data, and safety analytics.


Perks & Benefits

  • Competitive salary & performance benefits (undisclosed in JD).

  • Flexible / remote work options within India.

  • Learning & development, mentoring, career ladder progression.

  • Global, multicultural safety & medical writing teams.


Company Snapshot

Parexel is a leading global CRO (Contract Research Organization) delivering end-to-end clinical research, pharmacovigilance, regulatory, and safety medical writing services. With a strong focus on patient safety, GxP compliance, and global submissions, Parexel partners with top biopharma companies to accelerate development and ensure robust post‑marketing surveillance.


Work Mode

Remote / Hybrid – India (roles also listed for Hyderabad & Bengaluru).


Call to Action

Ready to advance your pharmacovigilance and safety writing career with a global leader? Apply now and help shape safety strategy, signal management, and regulatory excellence at Parexel.