Title: Sr. Director, Pharmacovigilance/ Drug Safety
Position Type: Permanent
Location: Raleigh, NC
Brio Resource Group is a search firm committed to providing rare pharmaceutical talent on an executive search basis to the Pharmaceutical, Biopharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging companies. Our many years of experience, subject matter expertise, proven search process and genuine passion to deliver rare talent defines Brio.
Brio Resource Group is seeking a highly qualified Sr. Director, Pharmacovigilance/ Drug Safety for a permanent position with our client, a medical device company. This industry leading company believes that innovation drives success.
The ideal candidate for this position would be a team player who is extremely detail oriented looking to join a company that is rapidly changing the healthcare industry.
We welcome the opportunity to provide a full job description upon resume review
Support the Drug Safety Department including the medical review and analysis of adverse event reports for processing and reporting to regulatory bodies.
Responsible for the Clinical Significance, Medical Summaries, and any other medical/clinical portions of Periodic Reports to the FDA as well as final approval of each report for submission.
Serve as medical expert for internal functions including, but not limited to, Health Hazard Evaluations and Corrective Action and Preventative Action Plans (CAPA).
Serve as a medical expert for OUS regions where necessary which includes, but is not limited to, review of Periodic Safety Update Reports.
Oversee and coordinate any medical evaluations for RiskMAP/REMS obligations.
Direct Company Core Data Sheet development, review, and update.
Serve as Drug Safety Physician in support of Clinical Operations which may include on-call availability.
Serve as back-up Medical Reviewer for Promotion and Advertising Review Committee (PARC) as needed.
Health care professional MD/DO licensed to practice in the US or PhD in Epidemiology with clinical background preferred.
A minimum of 5 years clinical/practical experience in a relevant clinical environment.
A minimum of 2 years of Pharmacovigilance experience in Clinical Safety or Post-Marketing Safety including thorough knowledge of FDA and ICH safety reporting regulations and guidelines. Any experience at the FDA, EMEA or other global regulatory authority is a plus.
Strong oral and written communication skills
Comfortable and capable of utilizing software programs such as Excel, Word, and PowerPoint
Formal training in Epidemiology a plus
Sound organizational skills with the ability to prioritize tasks
Demonstrated project management skills
How To Apply:
Once you click “APPLY” an appropriate member of our executive recruitment team will review your credentials and respond to arrange an initial interview to review your credentials and career objectives.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.