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Sr. Director, Safety & Risk Assessment
Philadelphia, PA

The Medical Affairs group at our client is comprised of a team of experienced physicians and well trained professionals and offers medical services for clients at both local and global levels. The company's experience and expertise covers all relevant areas for medical product support ranging from clinical development to post marketing surveillance and includes: consultation; complete pharmacovigilance services; a global drug safety data base system; medical writing as well as training. In addition, the company also offers the management of SAE reporting, written periodic safety update reports (PSURs) and SOPs. The medical affairs team also provides full pharmacovigilance coverage for marketed products with the use of a worldwide, fully validated and 21-CFR compliant safety data base system (ARISg).

The Senior Director, Safety and Risk Management will lead and manage outsourced Post-Marketing Surveillance projects, provide medical oversight to the communication of safety issues (e.g. lab report, CRF, and endpoint review) to staff and liaise with sponsors on IND safety projects. The Sr. Director Safety and Risk Management will help drive the growth and development, both internally and externally, of the CRO's Drug Safety team by developing and training direct reports, and collaborating with the business development group to expand business for the Drug Safety and Risk Management department. The incumbent will also monitor the regulatory landscape for emerging trends involving drug safety and risk management issues.

Some medical monitoring may be required. Travel to client sites approximately 20%.

If you would like to receive a detailed position description and learn more about this position, please contact Randi Schoenfelder at 732-625-1708 or via e-mail.