Medical Director, Pharmacovigilance and Risk Management

San Francisco, CA, United States
Nov 04, 2020
Biotech Bay
Required Education
Position Type
Full time
Who You Are

The Medical Director, Pharmacovigilance serves as the product safety lead for assigned study/product, and are accountable for executing the safety and risk management activities of assigned clinical development projects/marketed product to enable the safe and effective use of QED's products by patients and healthcare providers. The jobholder should be able to utilize subject matter clinical and pharmacovigilance expertise, combined with product knowledge, to identify and evaluate potential safety signals; they should also be able to support decision-making on a risk/benefit evaluation. The individual will need to be able to work cross-functionally and develop strong relationships with key stakeholders such as external CROs, Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs & others support ongoing clinical trials and overall lifecycle of QED products. The Associate Director/Director, Pharmacovigilance, and Risk Management is an individual contributor role and reports to the VP Pharmacovigilance and Risk Management.

  • Serve as a product safety expert & point of contact for assigned QED studies/products (internal & external)
  • Represent PV in project teams and study teams, and provide expert medical and safety knowledge regarding safety issues
  • Collaborate closely with clinical development, clinical operations, and regulatory affairs, medical affairs teams to ensure alignment with risk management plans and collection of safety data
  • Review and provide analysis for study-related documents including IB, ICF, and safety management plans
  • Perform/provide oversight for medical review of ICSRs from all sources for assigned product
  • Help develop and lead benefit/risk assessment and risk management strategies in collaboration with VP Pharmacovigilance
  • Evaluate safety data, provide input on signal detection activities, and continuously assess the benefit/risk ratio and design and implementation of risk management & mitigation activities; prepare the presentation and present data at quarterly signal detection meetings
  • Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report; DSUR)
  • Participate in production and maintenance of risk management plans and safety communication (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties, as applicable
  • Represent PV and participate in labeling committees as required (prepare, evaluate & review material to be present with Safety Risk Management)
  • Responsible for medical coding (AEs, ConMeds, Medical History, etc.) review of clinical trial data in conjunction with clinical development
  • Responsible for collaboration & review of protocols, ICFs, CSRs, IB, narratives, etc. & provide feedback to medical writers in a timely manner
  • Collaborate with Clinical Operations, Clinical Development, Regulatory, Quality & Compliance for inspection readiness
  • Support Medical Affairs and responsible for the review of medical Info letters, other similar outward communication
  • Contribute to the development, review, and update of Drug Safety/Pharmacovigilance SOPs, drug safety processes, Safety Data Exchange Agreements and other safety-related tasks to support the development of the department infrastructure and business needs

Education, Experience & Skills Requirements
  • M.D. or educational equivalent is required. U.S. Licensure and Board Certification are preferred
  • Minimum two (2) years seeing patients in either clinical practice or relevant setting; minimum (1-2, Associate Medical Director)/(3-5, Director) years in Pharmacovigilance & Drug Safety
  • Oncology and rare disease experience is a plus
  • Experience filing NDA/MAA is a plus
  • Excellent medical knowledge, and experience applying medical knowledge to the interpretation of individual case review, as well as aggregate data
  • Excellent medical writing skills, and previous experience reviewing and/or contributing to PBRERs, DSURs, PADERs, and other safety surveillance reports
  • Experience in Argus (or similar) safety database preferred; experience with MediData/InForm preferred; experience using Spotfire is a plus
  • Excellent oral and written communication skills and presentation skills
  • Demonstrate flexibility, open-mindedness, adaptability, and act nimbly in a fast-paced small company environment
  • Ability to operate with some/minimal direction
  • Ability think clearly and decisively and present independent, reasoned solutions to identified safety issues
  • Experience working in a team environment, including supporting other team members when necessary; promote collegiality and teamwork among peers

What we offer
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; act nimbly, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so