Associate Medical Safety Director- Sponsor Dedicated (Home-Based)

Our ever-growing Lifecycle Safety Medical team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes, but is not limited to providing and maintaining of PV and risk management expertise to internal and external stakeholders, maintaining knowledge relevant to allocated product portfolios, conducting medical evaluation of post-marketing adverse drug reactions, review and contribution to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, preparation, and/or contribution to responses to questions from health authorities, reviewing and contributing to periodic aggregate reports, contributing to safety review of study protocols, investigators brochure and other reference safety information, and serving as an internal consultant for any medical support for pharmacovigilance operations.

Role responsibilities

Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile

Leads signal detection and analysis, including, signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriate

Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports

Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies

Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up

Providing safety oversight and contribution for label development, review, and updates

Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document

Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams

Representing safety and clinical data review findings during internal and external stakeholder meetings

Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed

Do you have the skills, experience and qualification required for the role:

A medical degree from an accredited and internationally recognized medical school

Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience

Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process

Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature

Experience in Signal detection, Aggregate reports and Risk management.

Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing

Ability to establish and meet priorities, deadlines, and objectives