In search of a physician career change opportunity or a new non-clinical career? An executive search firm is working with a biotechnology company in New Jersey to fill the position of Safety Medical Director/Senior Director.
GENERAL SUMMARY:
Provide medical expertise for all safety-related issues, which include but not limited to the following:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Medical review, assessment, reporting, and follow-up of individual and aggregate SAE reports.
2. Ongoing safety surveillance and signal detection.
3. Development and implementation of risk management program for the development products.
4. Communication of safety issues to project teams and other stakeholders within the company and/or corporate partners.
5. Development of responses to safety-related communications, including risk benefit analysis for submission to global and US regulatory bodies in support of clinical development, regulatory approval, sales & marketing, etc.
6. Provide medical input to periodic reporting documents (PSURs, Annual Safety Reports, ad-hoc reports, etc.) and other clinical regulatory documents such as, Core Data Sheets, Company Core Safety Information, Investigator’s Brochures, Clinical Study protocol, CRF, Clinical Study Reports, Clinical Summaries and Clinical Overviews (benefit-risk evaluation).
7. Provide medical safety information as requested.
8. Ongoing training for project teams
9. Contribute to investigator meeting presentations
10. Assist senior management in making presentations to potential clients when appropriate.
11. Demonstrate a thorough understanding of Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs.
12. Demonstrate a thorough understanding of applicable regulatory standards in the countries where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations.
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:
1. Medical degree and broad based post graduate as well as 3 – 5 years of industry drug safety/ pharmacovigilance experience. Oncology experience is a plus.
2. Ability and willingness to travel approximately 15% of the time (4 days per month).
3. Ability to review and evaluate clinical data.
4. Outstanding oral and written communication skills.
5. Thorough knowledge of drug safety regulations and guidelines in the US and other ICH regions.
6. Ability to successfully manage and prioritize multiple critical issues simultaneously.
If you are interested in this position, please email a CV and cover letter to info at prnresource.com and we will provide it to the executive search firm looking to fill the position.
AS 3-23
