Description Major duties and responsibilities: Provides Pharmacovigilance (PV) expertise for assigned products
Maintain PV expertise, and understanding of international safety regulations and guidelines
Provide and maintain PV and risk management expertise to internal and external customers
Maintain knowledge of product, product environment and recent literature
Communicate and represent PV data evaluation, interpretation and summary or conclusions as relevant
Responsible for signal detection and analysis
Review, prepare, and/or contribute to responses to questions from health authorities, ethics committees, Internal Review Boards (IRBs), external partners
Manage product safety alerts, as needed
Identify and implement proactive safety analysis strategies to further define the safety profile for
Provide proactive risk assessment
Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report, Health Hazard Evaluation
Lead the preparation of Clinical Overview to support labelling changes
Lead the Safety part of the Company Core Safety Information (CCSI) creation and up
Qualifications Skills and Education:
MD Degree. Board Certified/Board eligible
Minimum 3 years of total experience in international Pharmacovigilance or equivalent relevant industry experience with relevant clinical experience considered.
Excellent clinical judgment
Capability to synthesize and critically analyze data from multiple sources
Ability to communicate complex clinical issues and analysis orally, including formal presentations,
and in writing
Able to develop and document sound risk assessment
Demonstrates initiative and capacity to work under pressure
Demonstrates leadership within cross-functional team environment
Excellent teamwork and interpersonal skills are required
Fluent in English (written and spoken).