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Fresenius Kabi is hiring experienced Aggregate Medical Writers for its Global Vigilance team in Gurgaon. This on-site pharmacovigilance role is ideal for professionals with 4–9 years of experience in aggregate safety report authoring, including PSURs/PBRERs, RMPs, ACOs, PADERs, and signal reports. If you are seeking a high-impact medical writing career with global exposure and structured growth, this opportunity aligns well with your expertise.
Key Responsibilities
- Author and/or review aggregate safety reports: PSURs, PBRERs, RMPs, ACOs, and PADERs.
- Conduct systematic literature reviews to identify signals and significant safety information.
- Ensure compliance with global pharmacovigilance regulations and internal SOPs.
- Collaborate cross-functionally with safety physicians, PV operations, and regulatory stakeholders.
- Contribute to signal evaluation narratives and safety strategy documentation.
Qualifications & Experience
- Education (Mandatory): PhD / BDS / M.Pharm / PharmD
- Experience: 4–9 years in Pharmacovigilance Medical Writing
- Expertise: Aggregate report authoring (PSURs/PBRERs, RMPs, ACOs, PADERs), signal reports
- Skills: Excellent scientific writing, regulatory acumen, literature review, stakeholder communication
- Work Mode: Work from Office (Gurgaon) with one-day flexi option
Behavioral Competencies
- Strong interpersonal communication and advanced scientific writing skills
- Proven ability to manage cross-functional, global projects
- Comfort working in a multi-cultural, international environment
Why Join Fresenius Kabi?
- Global exposure in drug safety and aggregate reporting
- Structured career growth in a leading healthcare organization
- Collaborative culture with best-in-class PV practices
- Competitive compensation and professional development support
How to Apply
Interested candidates should email their updated resume to:
Sonia.Kaushik@ext.fresenius-kabi.com
(Mention “Aggregate Medical Writer – Gurgaon” in the subject line.)
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