In search of a physician career change opportunity or a new non-clinical career? The client of an executive recruitment firm, a well known pharmaceutical company located in New Jersey, is in search of the following professional: Director, Drug Safety.
Responsibilities:
As a member of the Medical Evaluation Group, ensure the safe use of Company products and thereby contributing to Company Products business success throughout the life cycle.
* Proactively identify potential safety signals arising from clinical 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 Company clinical teams and into Life Cycle Teams.
* Represent Company 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 Plan.
Qualifications:
MD with 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. Ability to evaluate, interpret and synthesize scientific data (analytical thinking). Ability to travel internationally.
Highly competitive base salary plus benefits and incentives.
If you are interested in this position, please send a cover letter and CV to info at prnresource.com, and we will forward it to the recruiter looking to fill the position.
BR 12-14
