Medical Safety Director 53 views

About Medi Careers

As a trusted and forward-thinking specialist recruitment process outsourcing firm, we specialize in proactive sourcing and placement of top talent with exceptional skills around the world. We curate talent pipelines for top employers and create access to career opportunities.

Why a Career Transition as a Medical Safety Director?

A Medical Safety Director plays a pivotal role in providing medical, scientific and therapeutic expertise on pharmacovigilance services. As a Medical Director will include overseeing all medical safety activities, offering risk management guidance to stakeholders, maintaining knowledge of assigned product portfolios and evaluating post-marketing adverse drug reactions.

Core Responsibilities

• Provide reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile.
• Lead signal detection and analysis, including, signal detection strategy, frequency, and timing.
• Review 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.
• Provide 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.

Minimum Qualifications & Experience

• A Medical Degree from a recognized and accredited medical institute.
• 3 years of clinical practice experience with 2 years in the pharmaceutical or associated industry.
• 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.
• 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.

Core Competencies 

• Ability to establish and meet priorities, deadlines, and objectives
• Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed

Join our Talent Pipeline, Register or Apply

For secure registration, application, or to join our talent pipeline, visit our career page at Medi Careers. Medi Careers is a division of Think-Career™ Group and a proud member of APSO.

Disclaimer

At Medi Careers, we will ensure that no job applicant receives less favourable treatment because of their gender, marital or civil partnership status, sexual orientation, colour, race, ethnic origin, religion, disability, or age; nor be disadvantaged by any other conditions or requirements which are irrelevant.