Director of Drug Safety (MD)

The Position:Medical Evaluation Group is a team of physicians and scientists dedicated to safety signal detection and safety risk management ensuring the safe use of products and thereby contributing to Products business success throughout the life cycle.Proactively identify potential safety signals arising from cliical trials of drugs in development and from marketed products globally.
Critically evaluate potential safety signals and where necessary develop strategies to enable further assessment of safety signals.
Develop risk management strategies for significant identified safety risks.
Provide drug safety and strategic inputs into clinical teams and into Life Cycle Teams
Represent as Drug Safety representative at meetings with regulatory authorities and third parties such as licensing or co-development partners, consultants
Medical input in periodic reporting documents (PSURs; Annual Safety Reports; etc.) Core Data Sheets, Investigator's Brochures, Clinical Study Reports, Clinical Summaries and Clinical Overviews (benefit-risk evaluation)
Medical evaluation of single case reports
Author ASIME, issue workups, query responses (Health authorities, internal requests, health care providers), Risk Management PlanWho you are:MD
At least 3 years Pharma industry experience in Drug Safety or Clinical Development
Good knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation
Good knowledge of US and EU pharmacovigilance regulatory requirements
Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions
Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
Team player with abiity to function in a multi-disciplinary environment
Self-motivated, able to prioritize and plan effectively
Attention to detail
Good negotiating and influencing skills
Willingness to undertake international travel