We are seeking a highly skilled, dedicated, and experienced Aggregate Report Writer to join our pharmacovigilance team.
Qualifications:
• Mandatory: B. Pharm, B.D.S., B.A.M.S., or an equivalent life sciences degree
• Desirable: M. Pharm, Pharm D.
Preferred Experience:
Candidates must possess 5-7 years of proven experience in aggregate report writing, with significant hands-on experience in authoring PSURs, PBRERs, and PADERs
Location: This is a full-time, on-site position at our office in Airoli, Navi Mumbai. Remote or hybrid work arrangements are not available.
Competencies:
Essential:
• In-depth knowledge of pharmacovigilance processes and global aggregate safety reporting regulations.
• Good scientific writing skills to synthesize complex safety data into clear, compliant documents.
• Proficiency in Microsoft Excel for data analysis.
• Proficiency in Microsoft Word for document preparation and formatting.
• Excellent communication and interpersonal skills for team collaboration.
Desirable:
• Proficiency in handling safety databases.
• Familiarity with medical coding dictionaries (e.g., MedDRA, WHO-DD).
Interested and qualified candidates are encouraged to apply by sending their resume to vivek.poojary@alkem.com with the subject line "Aggregate Report Writer Application."
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