Manager, Pharmacovigilance Operations
Mountain View, CA /
Clinical Research & Development – Clinical QA and Safety /
/ Hybrid
About IGM Biosciences, Inc.
IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases, and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology, and inflammation targets. For more information, please visit www.igmbio.com.
IgM Antibodies and Autoimmune and Inflammatory Diseases
Antibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases, and IgMs are the first antibody defense against a pathogen infection. We are committed to exploring how the unique structure and binding properties of our IgM platform can improve outcomes for patients with these serious conditions.
IgM Antibodies and Oncology
IGM Biosciences has a T cell engager program, a receptor cross-linking agonist program and a targeted cytokine program in clinical studies for the treatment of patients with solid tumors and hematological malignancies.
Our Manager, Pharmacovigilance (PV) Operations will oversee PV vendor operational deliverables and ensures that these deliverables meet quality standards set by vendor contract and IGM and vendor SOPs and policies. The manager will ensure that vendor case processing is conducted on time and case closure meet regulatory reporting requirements. The position may support the editing or QC of all adverse experience reports and periodic safety reports (e.g. DSURs). This position impacts timely and quality deliverables. He/she must have experience and a strong desire to work in a growing company and bring strong management, collaboration and influencing skills to the table.
Qualifications:
This role will require a minimum of 5 years of pharmaceutical, biotech or CRO pharmacovigilance experience and a proven track record of successfully overseeing safety aspects of clinical trials, either directly or through third party service provider.
· BA, RPh, RN or equivalent degree in a science or healthcare related discipline
· Advanced knowledge of PV clinical case processing, workflow, global clinical safety/PV regulations, ICH guidelines and FDA/EMA regulations regarding safety
· Highly experienced with safety databases (Argus) and safety database management
· Proficient in MedDRA
· Experienced in query/report generation and adverse event software (clinical and safety databases)
· Advanced knowledge of compliance and quality management processes within PV
· Experienced in reviewing and preparing aggregate reports/listings (ASRs, IND annual reports and ad-hoc requests) for investigational products is preferred
· Strong event assessment/review/documentation and Project Management Skills
· Knowledge of safety review process for IBs, protocols, informed consents, data outputs, and final study reports
· Attention to detail in composing and proof-reading materials, establishing priorities and meeting deadlines
· Ability to build strong relationship with safety vendors and across internal functions
· Knowledge of SAE reporting via EDC is preferred
· Experience implementing Rave Safety Gateway preferred
· Experience in oncology and autoimmunity therapeutic areas strongly desired
· Knowledge of Argus, Medidata RAVE, MS Word, Excel, PowerPoint, and Outlook
Responsibilities:
· Implements and monitors compliance with internal procedures, regulatory requirements, and vendor contractual requirements with PV.
· Collaborates with internal departments to supports and develop standard operating procedures/working practices/collection forms and adheres to company and departmental SOPs as required.
· Assists or leads the development of policies, SOPs, work instructions, as required.
· Develops and deploys standard metrics on compliance reporting and KPIs for vendor performance including issue tracking processes
· Works in Argus database to pull reports, review data, and ensure quality standards are met
· Maintains effective working relationship with the safety vendors and internal stakeholders to ensure smooth running of this function and to serve as a resource for timely issue resolution
· Ensures the receipt, assessment, tracking, follow-up, and reporting of SAEs are done on time and with acceptable quality standards.
· Reviews adverse event reports, narratives, follow-up requests, and coding adverse events in MedDRA in conjunction with medical monitors in preparation for finalization of reports as required.
· Prepares line-listings and case narratives as requested for safety reviews, as required.
· Assists with submission of expedited reports to Regulatory Authorities and Clinical Investigators.
· Contributes to the timely preparation of ad-hoc and aggregate reports, including DSURs monthly SUSAR Line-Listing Reports, IND annual reports, liaising with managers, physicians, and pharmacovigilance colleagues as appropriate.
· Prepares and maintains internal filing systems, archives safety files and scans source information for archival in electronic systems.
· Demonstrates ability to communicate effectively with personnel of various disciplines both inside and outside of the company, regarding aspects of product inquiries and collection of safety data.
The typical annual salary range for this full-time position is $115,000 - $150,000, plus eligibility for cash and equity incentives.
This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.
Actual individual pay is determined by demonstrated experience and internal equity alignment.
We offer a fast-paced, collaborative, team-based, and family-like work environment.
One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:
· Medical, dental and vision insurance.
· The full premium amount for our employees and their dependents is covered by IGM
· FSA (Flexible Spending Account)
· STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
· 401(k) Plan
· 120 hours of Paid Time Off, 5 sick days per year, 10 holidays
· Cell phone & internet subsidy
· Employee Referral Bonus Program
· Annual training budget for professional development
· Commuter Benefit
· Annual bonus program
· New hire stock options
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.
