Karyopharm Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible that is responsible for the medical oversight of global pharmacovigilance activities of clinical trials and product development. You will hold a leadership role, taking responsibility for all PV activities for clinical trials and clinical development products.

RESPONSIBILITIES:

• Ensuring compliance of Pharmacovigilance with GVP, GCP and all applicable global regulations:
  • Ensure the establishment of monthly safety reporting compliance metrics of individual (e.g. ICSRs, SUSARs, etc), aggregate, and periodic reports (e.g. DSUR, ASR) are 100% compliant both in terms of quality and timelines for in-house and contracted services.
  • All necessary SOPs, work instructions, and business practices are written and complied with by the department
  • Oversight of PV Vendor(s)
  • Partnering with Quality and Regulatory teams to ensure compliance with all required regulations and processes
  • Ensure that the established PV department is in a state of inspection readiness.
• Provide guidance for the development of worldwide pharmacovigilance strategies with Karyopharm’s goals
• Hold line management responsibility for the PV department: recruit necessary resources, provide strong line management and leadership to a stable team of safety professionals.
• Establish and maintain policies and procedures for the Clinical Drug Safety Department.
• Perform or provide oversight for the medical review of serious adverse event reports (SAE’s) to ensure accuracy, integrity and completeness of safety information and to ensure consistency of medical coding of safety data.
• Management of the safety product profiles of products, including signal detection, and responsibility for risk management activities (e.g. risk identification, risk evaluation and development of appropriate risk and safety management plan (SMP) documentation). through the assessment of single case safety reports and aggregate trend analysis.
• Develop and manage department budget
• Ensure ongoing evaluation of overall safety profile for Karyopharm’s investigational products serving as the product safety expert working in partnership with medical monitors to bring potential safety issues to the attention of the clinical team and senior management.
• Support clinical operations teams with respect to safety related issues as required.
• Provide input and review of responses to regulatory questions with regard to safety pharmacovigilance activities
• Develop and author all relevant safety sections of NDAs, MAAs, and other marketing applications as required
• Provide support for safety sections of clinical documents including the review and approval of the safety portion of protocols, annual reports, final study reports and other as needed
• Support development and maintenance of product benefits risk profile.
• Evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety Pharmacovigilance submissions.

• MD degree required
• Knowledgeable of pharmaceutical development
• 8-10 years of experience of pharmacovigilance experience in a global environment
• Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments
• Expertise in SAE analysis,SAE coding, and signal detection
• Familiarity with common safety databases, including ARGUS
• Strong organizational, management, teamwork and interpersonal skills required
• Excellent clinical judgement and ability to communicate complex clinical issues in a scientifically sound and understandable way.
• Experience working with all levels of management and consulting with key business stakeholders and ability to influence for greater outcomes.
• Embrace our core values Innovation, Courage, Urgency, Resilience, Energy (ICURE)
• Possesses strong written and verbal communication skills

At Karyopharm, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity. We maintain broad salary ranges to reflect market conditions and the specialized nature of our work. The anticipated base salary range for this position is $350 K –$430 K USD.

At Karyopharm, we live and demonstrate our ICARE values every day! If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between. What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.

Check out our Culture Video!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), team members enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
• Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
• Wellness Program with a monthly stipend. 
• Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
• Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
• Cell phone allowance