Director, Safety Risk Management Scientist
About The Position
Experienced safety surveillance and risk management scientist with a degree in life sciences (Pharmacy degree, Nursing degree or master’s degree in health-related field) and 10+ years’ experience in safety surveillance and safety risk management. Have an in depth understanding on FDA and EU-GVP guidance on safety signal management, periodic report development, safety risk management and benefit-risk assessment. Detail-oriented and have strong written, organizational and communication skills. Will work collectively with all relevant functions for DSPV including R&D medicine, clinical operations, data management, biostatics, regulatory, quality, manufacturing and medical affairs.
Requirements
- Degree in life science (pharmacy , nursing or MS in health related field)
- At least 10 years of experience from pharmaceutical/biotech companies predominantly in safety surveillance and safety risk management.
- Excellent verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Proficient with Microsoft Office Suite or related software.
Nice To Haves
- Advanced degree in epidemiology (desired)
Responsibilities
- Performs proactive safety monitoring and signal detection for assigned products and presents the findings to cross-functional team and safety governance meetings.
- Authors signal assessment report as part of signal detection process, develop safety monitoring plan and pharmacovigilance plan as required.
- Manages cross-functional safety management team for the assigned product(s).
- Authors safety risk management plan for products under clinical development and post-marketing.
- Authors safety sections/modules for BLA/MAA submission dossier (SCS, ISS, Clinical overview).
- Oversight on the activities related to the periodic reports preparation (DSUR) in collaboration with the assigned external vendor(s).
- Authors and/or reviews documents or sections of key documents as they relate to safety and safety monitoring (e.g.: protocols, protocol amendments, Investigator Brochures, Informed Consent Forms etc..
- Authors and/or reviews section of key CRO documents as they relate to safety and safety monitoring (Safety Management Plan, Medical Monitoring Plan, SAE Reporting, Communications plan, etc.
- Contribute to the development and revision of safety surveillance & risk management SOPs, template.
- Collaborate with PV Operation team on medical review of ICSRs and clinical study team on safety surveillance deliverables for the assigned product.
- Participate in PV audit and inspections.
- Participate in PV audit and inspections
Benefits
- performance-based annual cash bonus
- new hire equity grant
- eligibility to be considered for annual equity awards
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
