In search of a physician career change opportunity or a new non-clinical career? A client of an executive search firm, a well known pharmaceutical company located in New Jersey, is in search of the following professional.
Senior Director, (Drug Safety)
Responsibilities:
Oversee clinical operations of the Drug Safety Department including development and review of safety reports, assessment of safety signals, and contribution to regulatory and clinical regulatory documents.
* Adverse event reporting to the regulatory authorities.
* Follow-up of adverse events as necessary with study sites and industry partners.
* Communication of safety issues to project teams and other stakeholders within the company.
* Participate in the on-call safety monitoring procedure.
* Ongoing training for project teams in therapeutic areas as requested.
* Review of study documentation (protocol, CRF, etc.).
* Contribute to investigator meeting presentations.
* CRF safety review.
* Contribute any necessary clinical interpretation into integrated clinical and statistical reports.
* Demonstrate a thorough understanding of Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs.
* Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations.
Qualifications:
Medical degree and broad based post graduate and industry experience with Oncology experience strongly preferred. Ability and willingness to travel approximately 10% of the time (4 days per month). Ability to review and evaluate clinical data. Familiarity with industry principles of drug development, pharmacology, biostatistics, clinical trial methodology and pharmacoepidemiology.
Highly competitive remuneration including incentives and overall package.
If you are interested in this position, please send your CV and a cover letter to info at prnresource.com, and we will forward them to the search firm looking to fill the position.
