Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Associate Director, Global Patient Safety - Ophthalmology role.
Rezi rewrites your resume against Regeneron Pharmaceuticals's job description. Free.
Tailor your resume to this Associate Director, Global Patient Safety - Ophthalmology role.
Rezi rewrites your resume against Regeneron Pharmaceuticals's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Associate Director, Global Patient Safety - Ophthalmology posting at Regeneron Pharmaceuticals — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Associate Director, Global Patient Safety - Ophthalmology posting at Regeneron Pharmaceuticals — free, in seconds.
About the Role
The Associate Director of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases. This includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessments within a fast-growing, science-driven organization.
Responsibilities
- Complete signal detection activities in line with approved safety surveillance plan.
- Perform signal evaluation for any identified signals and author the safety evaluation reports.
- Manage preparation and review of safety documents including DSUR, PSUR, RMP, and responses to health authority queries.
- Prepare and deliver presentations at Signal Management Team (SMT) meetings.
- Participate in clinical study team meetings for assigned compounds.
- Participate in other risk management activities as appropriate for assigned compounds.
- Represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), and external teams.
- Act as a resource for medical review of assigned compounds.
- Actively participate in process improvement initiatives, including the development and maintenance of relevant SOPs, WIs, and supporting documents.
Requirements
- Minimum a Master's, PhD, or PharmD (Terminal Degree preferred).
- 10+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority.
- Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 8-10+ years of risk management or relevant clinical experience in pharmaceutical/biotech industry or health authority.
- Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
- Ability to work with a safety system database for medical case review and simple queries.
- Proactive and self-disciplined with the ability to meet deliverables, effectively use time, and prioritize.
- Ability to effectively communicate safety findings (verbal and written).
- Background that includes Master's, PhD, or PharmD.
- Clinical experience and/or industry experience in the TA of interest is a plus.
Skills
- Signal detection
- Signal evaluation
- Safety document preparation and review (DSUR, PSUR, RMP)
- Presentation delivery
- Risk management
- Cross-functional team representation
- Medical review
- Process improvement
- SOP development and maintenance
- Pharmacovigilance
- Safety system database utilization
- Communication (verbal and written)
Location
- Uxbridge, UK
Work Type
- 3 days per week on site
- 25% Travel may be required
Experience Level
- Associate Director
- 10+ years of relevant risk management experience
- 8-10+ years of risk management or relevant clinical experience
Education Level
- Master's
- PhD
- PharmD
- Terminal Degree preferred
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.