In search of a physician career change opportunity or a new non-clinical career? An executive search firm is looking to fill the position of Director, Drug Safety, for a pharmaceutical company located in northern New Jersey.
Responsibilities include:
- 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 or PhD or PharmD or a combination of either 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.
- Willingness to undertake international travel.
Highly competitive base salary plus benefits and incentives including relocation.
If you are interested in this position, please email a cover letter and your CV to info at prnresource.com, and we will forward them to the executive search firm looking to fill the position.
BR – 4-08
