Description

Support Global Patient Safety (GPS) Safety Scientists and Safety Strategy Leads with regards to safety medical writing (SMW) activities.
Author a wide range of pharmacovigilance documents including but not limited to various Periodic Safety Reports, Signal Evaluation Reports, Safety Strategy and Core Benefit-Risk Documents, Risk-Management Plans, Patient Safety Narratives and Health Hazard Reports.
Author responses to Health Authorities queries (ad-hoc queries, queries following submission of PBRER/PSUR, such as PRAC inquiries, etc.).
Effectively and clearly communicate technical, medical, and scientific information in critical submission and internal PV documents in order to deliver high quality reports within the specified timelines.
Review (both self- and peer) of SMW deliverables for data accuracy, consistency, and ensuring alignment with the processes, templates and regulations.
Participate in meetings related to key PV activities.
Collaborate cross functionally for continuous improvement of standards and best practices for medical writing.

Responsibilities

Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
Excellent written and spoken English (including medical terminology) with a familiarity with AMA style guide.
Profound pharmacovigilance experience (5 to 9 years’ experience in drug/patient safety) required.
Demonstrated experience in Periodic Safety Reports of interpretation & presentation of aggregate safety data.
Strong knowledge of regulations and guidelines (FDA, EMA, ICH, EU GVP, etc.).
Experience in signal management, benefit-risk assessment, literature surveillance is beneficial.
Proven experience in ability to consistently produce documents of high quality and express complex data in a concise and easy-to-read way.
Comprehensive experience in working in cross-functional, global teams, across different regions and time zones.
A flexible attitude with respect to work assignments and new learning; readily adapts to changes.