Senior Manager, Pharmacovigilance
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Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Global Drug Safety & Pharmacovigilance Operations
- Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products
- In partnership with Clinical Research Organizations (CROs) oversee intake assessment processing medical review and reporting of ICSRs from clinical trials adhering to established processes and timelines
- Ensure timely submission of expedited and periodic safety reports to Regulatory Authorities IRBs/ECs clinical investigators and business partners
- Support preparation and submission of DSURs periodic safety reports/listings and updates to Investigator Brochures (IBs)
- Develop maintain and execute Safety Management Plans for clinical studies
Clinical Development & Regulatory Affairs Support
- Contribute to safety sections of clinical study protocols informed consent forms (ICFs) clinical study reports (CSRs) and IND/NDA/MAA/CTAs (as applicable)
- Review clinical trial safety data and assist with data cleaning for ongoing studies
- Participate in periodic safety reviews signal detection and risk evaluation activities
- Maintain Reference Safety Information for ORIC products and co-administered IMPs
- Support launch readiness activities including development of post-marketing pharmacovigilance processes development and maintenance of Risk Management Plans (RMPs) and REMS (as applicable)
- Assist with preparation for regulatory inspections and audits
Cross-Functional Collaboration
- Participate in internal Safety Management Teams and governance meetings
- Partner with Clinical Regulatory Affairs Medical Affairs Quality and Commercial teams
- Support safety training for internal stakeholders and investigators
Vendor & Compliance Oversight
- Support oversight of pharmacovigilance vendors and service providers
- Ensure Safety Data Exchange Agreements (SDEAs) are implemented and maintained
- Assist in development and maintenance of SOPs and training materials
Qualifications :
Required Qualifications
- Bachelors degree in life sciences pharmacy nursing or related discipline with demonstrated knowledge of medical terminology
- 12 years pharmacovigilance experience with Bachelors degree -or- 8 years experience and Masters degree -or- 5 years experience and PhD-including clinical trial and/or post-marketing experience
- Experience with small-molecule oncology products
- Working knowledge of global pharmacovigilance regulations including FDA EMA Health Canada and Asian Health Authorities (e.g. Japan PMDA South Korea MFDS)
- Experience using validated safety databases (e.g. Argus ARISg) and clinical trial databases
Preferred Qualifications
- Oncology experience in lung and/or prostate cancer
- Experience in biotech/ small pharmaceutical company or CRO environments
- Experience supporting NDA/MAA submissions and commercial launch
- Familiarity with REMS RMPs and post-marketing commitments
Skills and Attributes
- Strong strategic thinking combined with a hands-on execution-focused mindset
- Proven ability to collaborate and lead in a cross-functional matrixed organization
- Excellent written and verbal communication skills with the ability to convey complex data clearly
- Highly organized adaptable and comfortable working in a fast-paced evolving environment
- Mission-driven patient-focused and committed to scientific integrity
Additional Information :
The anticipated salary range for candidates who will work on-site at our San Diego location is between $150000-$180000. The final wage offered to a successful candidate will be dependent on several factors that may include title type and length of experience within the role type and length of experience within the industry education geography and other job-related factors.
ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristics.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Program Management
- FDA Regulations
- Management Experience
- Facilities Management
- Clinical Development
- Data Management
- Quality Systems
- Project Management
- Research & Development
- GLP
- Budgeting
- Leadership Experience
About Company
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high ... View more
