Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Post : Senior Medical Writer (Pharmacovigilance)
Primary Job Function
The primary function of the Manager Medical Writing is to provide medical writing expertise as well as project management support for periodic reports and signal evaluation reports.
This includes :
• Accountability for the preparation and project management of assigned safety reports to ensure compliance. Further it is the responsibility of the Manager Medical Writing to deputize for the Head Periodic Reporting and Medical Writing.
Core Job Responsibilities :
• Independently analyses pharmacovigilance safety data and produces written summaries and full reports based on applied clinical experience, current standards of medical care, and compliance with regulatory guidelines using scientifically based medical judgment.
• Performs job responsibilities in collaboration with the Global Medical Safety Experts, management, and cross-functional areas within Medical Affairs, Regulatory Affairs, Clinical Development and the Product Safety Teams.
• Responsible for the creation and oversight of project plans, which includes timeline management, preparation of business-critical regulatory documents, and the quality of key deliverables.
• Critically reviews and edits the written analyses of the Medical/Scientific Writer, assuring that documents are of the highest quality, appropriate for the designated audience, and reflect current medical standards.
• Participates in the identification, direction, and implementation of strategic business initiatives within the Periodic Reporting and Medical Writing Group.
• Assists with the development of training materials in regards to Periodic Reporting and Medical Writing.
• Mentors and coaches new Medical Writing staff and assists with onboarding and training plan.
• Proactively understands regulatory framework, trends & requirements related to Pharmacovigilance, clinical studies and global drug development.
• Actively contributes to minimizing patient and product risk by conducting pharmaceutical and medical assessment of information on drug risks including adverse reactions, drug interactions, toxicity and medication errors during periodic report preparation. This includes the consideration if safety data qualify as a new safety signal or as a new identified or potential risk, or may potentially alter any previous signal or risk assessment.
• Pharmaceutical advice and support of (Senior) Medical/Scientific Writer by provision of pharmaceutical expertise and assessment within the scope of report compilation.
• Supervision of pharmaceutical trainees.
• Minimum 5 years industry experience in Pharmacovigilance, Strategic Medical Affairs or Clinical Development.
• Broad and proficient understanding of medical conditions and disease state entities, able to critically evaluate pharmaceutical/medical data. Good knowledge on pharmaceutical drug technology.
• Experienced professional operating within the international arena, and working across functional areas.
• Good negotiating skills, tact and diplomacy. Advanced knowledge of standard business procedures, very good project management skills, proficiency in the use of Microsoft Excel, Word, Power Point, Outlook, e-room technology, and good electronic Common Technical Document (eCTD) knowledge and formatting skills (e.g. ISI Write
Experience : 5 years
Qualification : M.Pharma / B.Pharma / M.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance
End Date : 31st March, 2023
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