Manager/Senior Manager of Pharmacovigilance Operations
It takes a team to develop innovative cancer therapies!
Elevation Oncology, a clinical stage biopharmaceutical company united by our shared passion and purpose to develop and advance our pipeline of differentiated ADCs with broad therapeutic potential, including programs targeting Claudin 18.2 and HER3 has an opening for an experienced Manager of Pharmacovigilance Operations.
Elevation Oncology’s dynamic Pharmacovigilance (PV) team is looking for an experienced Manager of Pharmacovigilance Operations. This new team member will play a key role in optimizing drug safety operations across clinical development. Elevation Oncology’s PV works with CROs and global business partners which makes for diverse and complex PV environment.
The Manager/Sr. Manager of Pharmacovigilance Operations reporting to the Vice President, Clinical Data Sciences is responsible for supporting all PV activities for Elevation Oncology, including oversight of PV vendors, compliance monitoring, quality review of safety case narratives, and assisting with development/maintenance of PV procedural documents.
RESPONSIBILITIES
- Take part in the daily management of pharmacovigilance (PV) functions
- Provide sponsor oversight of responsibilities specified in Safety Management Plans
- Ensure compliance of internal/vendor SOPs, safety data exchange agreements with Elevation PV Partners, and global regulations
- Assist in quality review of safety case narratives
- Support processing and triaging PV mailbox emails
- Represent PV in selected Elevation clinical development or medical research project teams
- Assist in creation and maintenance of PV procedural documents
- Assist in development of PV related training materials for use by Elevation personnel and contractors
- Monitor key performance indicators of case processing and present findings
- Assist with other safety related activities and special projects as assigned
REQUIREMENTS
At least a BS in a Life Science degree and/or clinical degree (Pharm. D., RN, RPh.) required
- Minimum 5 years of hands-on experience in Pharmacovigilance operations
- Experience in SAE case management, case processing activities and development of case queries
- Strong quality focus, with a good understanding of quality systems
- Experience using Argus safety database and safety coding dictionaries
- Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines
- Excellent communicator, both oral and written.
- Strong medical writing skills
- Be proactive and use a risk-based approach in complex processes
Elevation Oncology is focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are rethinking drug development by seeking out innovative, selective cancer therapies that can be matched to a patient’s unique tumor characteristics.
If you share our beliefs and are interested in helping to further our mission, send your resume or CV to careers@elevationoncology.com
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.
Search Firms and Agency Representatives: Elevation Oncology is not accepting unsolicited resumes from search firms or agencies for any job posting. Resumes submitted to any employee of Elevation Oncology by any search firm or agency without an applicable contract in place will be the property of Elevation Oncology and no fee will be paid.