Pharmacovigilance, Drug Safety | Senior/Executive Medical Director or VP
Full Time
Seattle, WA 98119
Posted
Job description
Alpine Immune Sciences is applying our platform discovery technology to bring innovative new therapies to people living with serious or life-threatening illnesses or conditions, such as cancer and autoimmune/inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!
Primary Function
Responsible for strategic pharmacovigilance and risk management activities for all Company products.
This role is accountable for the medical pharmacovigilance activities in support of drugs in clinical development as well as future marketed products, in accordance with applicable pharmacovigilance standard operating procedures (SOPs), and FDA, ICH, and EU guidelines. This position includes medical review of individual case safety reports, literature review, safety assessments, periodic safety reports, signal detection, Risk Management Plan development and updates, support of regulatory filings and other safety related tasks.
Key Responsibilities:
Will establish, oversee and lead Pharmacovigilance (PV) activities for all Company products, including Safety Evaluation and Risk Management- Medical review of individual safety reports and emerging safety data (signal trending and detection)
- Contributes to:
- protocol development to ensure alignment with risk management plans and effective collection of safety information
- review and provide pharmacovigilance content for key study-related documents, e.g. IB, RSI, ICF, SMC/IDMC Charters
- preparation and review from on-going and completed clinical trials of periodic regulatory reports, e.g. DSUR
- analysis of safety data and presentation in Clinical Study Reports
- literature search reviews as part of signal detection
- safety communication to regulatory agencies or third parties.
- Facilitate production and maintenance of risk management plans and company core safety information
- Inform the Executive Leadership Team and other key stakeholders on the changing risk-benefit profile of company products and competitors’ products in clinical trials, based on analyses/evaluation of potential safety signals; implement appropriate safety updates and risk mitigation plans
- Lead responses and resolutions to safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
- Lead signal management activities and be a member of safety governance bodies
- Negotiate contracts, interact with, and supervise the activities of CROs/safety service providers and consultants for Pharmacovigilance services
- Provide input to Pharmacovigilance agreements and participate in alliance safety teams with external partner(s).
- Subject matter expert on safety regulations and operations
- Chairs Pharmacovigilance Committee meetings
- Provides guidance, mentorship and training to staff on pharmacovigilance best practices, risk management, and safety science.
- Participate in continuous improvement activities including systems design, performance measurement and quality management.
- Represents pharmacovigilance at health authority meetings, and audits or inspections.
Requirements:
MD, DO or equivalent with board certification or ex-US equivalent, at least 7 years of experience in drug safety, clinical safety, pharmacovigilance or risk management. Oncology and/or inflammatory disease safety science experience preferred.- Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines strongly preferred).
- In-depth knowledge of drug safety and pharmacovigilance practices based on current, local, and global regulations and guidelines for AE/SAE reporting, conducting clinical research, and ICH/GCP practices
- Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally in a fast-paced environment
- Excellent communication both written and spoken English.
- Prior experience with business partners a plus.
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.
We take care of our employees with competitive benefits package which includes premium medical, dental, and vision coverage for employees and their dependents, wellness programs, FSA and 401(k) plans. We believe that quality time outside the office is vital to our employees’ satisfaction at work. That’s why our flexible PTO plan encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).
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.
As a condition of employment, Alpine requires that employees are up to date with COVID-19 vaccination. In order to be considered up to date, employees must have completed a primary series of a SARS-CoV-2 vaccine, followed by a booster dose, as recommended by the CDC. Employees can submit requests for medical or religious exemption so that Alpine can consider possible accommodations.
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 during the COVID pandemic. 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!
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