Associate Medical Safety Director

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).