BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Life Sciences community.
We are currently looking for a (6mo) Contract Associate Director of Pharmacovigiliance Sciences to work for a leading San Diego area pharmaceutical company.
Key Responsibilities :
- Manage all pharmacovigilance activities for assigned products or therapeutic areas.
- Prepare and submit pharmacovigilance aggregate reports (e.g., DSUR, PBRER) in collaboration with safety physicians and stakeholders.
- Compile safety data for regulatory submissions, post-marketing assessments, and label updates.
- Lead the review and approval process of pharmacovigilance reports, coordinating with safety physicians and external vendors.
- Conduct safety surveillance and signal detection activities for assigned products.
- Organize and lead Safety Review Team (SRT) meetings, ensuring that all regulatory and Risk Management Plan (RMP) commitments are tracked and addressed.
- Represent pharmacovigilance in clinical programs, collaborate with Regulatory Affairs on expedited safety reports, and support Drug Safety Monitoring Boards.
- Provide guidance and oversight to vendors supporting pharmacovigilance activities for investigational and marketed products.
- Participate in PV audits and regulatory inspections as a subject matter expert.
- Occasional travel up to 15% may be required.
Qualifications :
- Bachelor’s or Master’s degree in a science-related field (e.g., BSN / RN, Pharmacy, PharmD) with 5+ years of pharmacovigilance experience.
- Experience in signal detection, safety surveillance, and risk management is a plus.
- Strong knowledge of FDA, EU, and ICH guidelines and regulations governing pharmacovigilance.
- Proficient in medical terminology and MedDRA.
- Excellent written and verbal communication skills.
- Capable of working independently and within a collaborative, fast-paced environment.
- Strong analytical, problem-solving, and adaptability skills.
- Effective planning, organization, and time management, with the ability to prioritize multiple projects.
What we offer :
As we work to develop innovations that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
- Full support and career-development resources to help you reach your potential
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Apply now and let's make work better!
Assistant/ Associate Director of Admissions
The University of California, Irvine School of Law is the culmination of several generations of revolutionary dreamers. Advanced knowledge of computer software including Microsoft Office Suite especially Excel. As part of this commitment, all applicants who accept an offer of employment must comply ...
Associate Director of Facilities Management
They are looking for an Associate Director of Facilities Management to oversee their locations in Los Angeles, Orange County, and San Francisco. They have state-of-the-art facilities and expert handling to keep collections safe. They offer storage, transportation, and management services. Supervise ...
Senior Associate Athletics Director, Chief Financial Officer (06564U) Intercollegiate Athletics 710
The University of California, Berkeley, is one of the world's leading institutions of higher education, distinguished by its combination of internationally recognized academic and research excellence; the transformative opportunity it provides to a large and diverse student body; its public mission ...
Associate Director, R&D Quality Business Partners
Associate Director, R&D Quality Business Partners. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Thorough knowledge of standards, systems, policies and procedures that enable QMS operations and compliance within the ...
Associate Program Director
As the nation's leading nonprofit organization committed to strengthening communities through youth development, healthy living, and social responsibility, the YMCA of San Francisco offers more than just a job--we offer you a career with a future and the chance to make a lasting difference in your c...
Associate Director of Operations (Inland Empire)
Associate Director of Operations for Inland Empire. Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, etc. Illumination Foundation (IF) is a growing non-profit organization dedicated towards disrupting the cycle of homelessness by providing targeted, interdisciplinary services...
Associate Budget Director
The Office of Budget & Planning provides campus management with the necessary information and analysis to make decisions regarding the most effective allocation and use of campus resources. The Associate Director, under the Budget Director's guidance, will lead annual budget cycle processes, ens...
Associate Director of Program, Planning, and Evaluation
The Associate Director is often the first line of contact representing the Cancer Center to an extensive array of individuals including, but not limited to, NCI staff, donors, patients, vendors, and both UCSF and non-UCSF faculty and staff. The Associate Director will support research hubs and other...
Associate Director of eDiscovery Operations
A leading eDiscovery technology and consulting firm headquartered in Washington DC is looking for an Associate Director of eDiscovery Operations. In partnership and collaboration with the Director, provide leadership and oversight of project teams, including managing team utilization, onboarding, tr...
Estate Planning Attorney Educator | Associate Director of Education | Senior Legal Education Specialist
We are actively seeking an Associate Director of Education for an esteemed organization leading the field of Estate Planning and Elder Law. Develop and implement top-tier educational programs in collaboration with the Director of Education. Apply today and be part of shaping the future of estate and...