Drug Safety Specialist

Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!

Alpine Immune Sciences is looking for a conscientious and energetic individual to join our pharmacovigilance team and play a valuable role in supporting Alpine’s growing clinical development portfolio. This individual will be responsible for working closely with the Senior Manager of Pharmacovigilance and our clinical physicians in the ongoing evaluation of the safety data in our clinical trials, and in ensuring the safety of our clinical trial participants. The primary responsibilities of the Drug Safety Specialist include initial notification distribution, electronic filing, and query resolution of reported Adverse Event data according to applicable regulatory guidelines/requirements, Standard Operating Procedures (SOPs) and clinical trial specific requirements. In this role, the Drug Safety Specialist will serve as the initial point of contact and recipient for reported SAEs and AEI’s.

Duties and responsibilities:

Key Responsibilities:

•Monitor the Drug Safety Inbox for all incoming SAE and AEI reports.

•Review reported SAE and AEI data for completeness and accuracy.

•Distribute the initial and follow‐up safety information to the study specific distribution list.

•Review case data entry in the safety database.

•Create and maintain SAE case folders for all SAE documentation.

•Complete applicable tracking of safety information. Create and maintain various SAE trackers.

•Generate queries for missing or unclear information and follow-up for resolution.

•Document and maintain query management with the clinical database and reconcile with safety database.

•Perform case closure and electronic filing of SAE related documentation.

•Contribute to the Quality Assurance and perform QC of processed SAEs.

•Attend internal and CRO meetings, as appropriate.

•Attend and present at Investigator Meetings.

•Prepare and submit periodic safety reports, as needed.

•Maintain knowledge and understanding of safety-related regulations and guidelines.

•Maintain a basic understanding of scope of work and budget for assigned projects.

•Perform other PV activities appropriate to experience and expertise.

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Desired Skills and Abilities:

•Understanding of medical and scientific terminology, principles of clinical research, clinical assessment of adverse drug events, international regulations, and reporting requirements.

•Ability to work independently, prioritize work effectively and work successfully in a matrix team environment.

•Self‐motivated collaborative team player with strong problem-solving skills.

•Excellent organizational skills and ability to anticipate needs and follow through.

•Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines.

•Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment.

•Consistently demonstrates commitment, dependability, cooperation, adaptability, and flexibility in executing daily tasks and responsibilities.

•Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meetings and/or bid defense meetings).

Education and Experience:

•Bachelor s degree in science or health care related field.

•A minimum of 2 years of experience in the pharmaceutical industry, with at least 1 year of experience in drug safety/pharmacovigilance.

•Thorough knowledge of US and ICH safety reporting regulations and guidelines.

•Experience entering data into a clinical or safety database.

•Proficiency and working knowledge of MS Office (Excel, PowerPoint, Word, SharePoint).

•Excellent written and verbal communication skills.

•Outstanding organizational abilities, with strong attention to detail.

#LI-DNI 

At Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a professional level position, with a compensation range of $100,000 - $120,000. Note that there is a strong preference for candidates to be located in one of the following five states: CA or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees’ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).

Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.

Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.

Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.

Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!