Vice President Pharmacovigilance and Safety Operations

Pharmacovigilance    ·       South San Francisco, CA       ·       Full time

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

Alector is seeking a highly motivated, experienced Vice President, Pharmacovigilance who can grow and lead the function. The Vice President will lead the Pharmacovigilance team, including Safety Operations. In addition, this individual will review all ICSRs in the safety database and will develop and lead surveillance activities as well as providing scientific/clinical/pharmacovigilance expertise for safety data analysis from various sources including pre-clinical studies, clinical studies, literature and other information sources. This individual will focus on the pro-active identification, evaluation, and management of identified and potential safety risks to patients for assigned Alector products throughout the product’s life cycle. 

Essential duties and responsibilities:

• Management of Pharmacovigilance Team

• • Oversee and manage the Safety Operations Team, Safety Surveillance and Safety Monitoring activities
  • Insure proper support/resourcing for programs and team
  • Continually improve the systems and processes
• ICSR Processing

• • Perform Sponsor Medical Review for all serious adverse events and adverse events of special interest in the Drug Safety Database
• Program Support

• • Safety Lead for all Alector assets and develop the safety strategy to assess/mitigate the clinical risk identified and potential effects in humans
  • Safety Lead providing as needed support, attendance of project and clinical team meetings on an as-needed basis
  • Lead DMC/DSMB activities focused on Safety and partner with the Clinical Lead to manage these meetings for all the clinical programs.
  • Influential member of the Alector Safety Management Team and Safety Committee
• Study Documents

• • Safety Lead for all Clinical Study Reports, Study Protocols, Investigator Brochures Perform review of risk rider language and informed consent forms (ICFs)
  • Develop the Safety summarizations
  • Review documents
• Program Level Documents

• • Perform review of Briefing documents as needed (Safety/Risk Information)
  • Medical evaluation of Vendor Signal Detection Activities
  • Review risk evaluation in Aggregate Safety Reports
  • Approve Literature Search Strategy to ensure identification of new potential risk associated with Alector’s products
  • Author Integrated Summary of Immunogenicity
  • Review Integrated Summary of Safety
  • Review CDP as applicable for risk mitigation planning
• Medical Coding

• • Review of coding in EDC (i.e. medical hx, concomitant medications, AE terms) – upon joint agreement with Safety and Clinical team
  • WHO Dictionary and MedDRA coding experience
• Other

• • Point of contact for Safety risks identified by Medical Monitor
  • Point of contact for Safety concerns/risks identified during Safety Surveillance Process / Aggregate Safety Reviews
  • iDMC attendee & lead for all safety inquiries/discussions, including preparation for the meetings
  • Lead/manage safety advisory boards, as necessary
  • Safety correspondence with Health Authorities
  • Informed of outcome of data review meetings

Education/experience/skills:

• MD degree with minimum of 10+ years of pharmacovigilance experience required; with previous signal detection/ safety surveillance and international experience.
• Board Certification with patient care experience is preferred.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies
• Experience in the preparation and authoring of aggregate safety reports, RMPs, and RSI
• Experience with antibody-based therapeutics strongly preferred, experience in neurology and/or oncology is additive.
• Previous work experience with a pharmaceutical company required
• Ability to apply principles, concepts and industry best practices governing pharmacovigilance and risk management in assigned projects.
• Strong verbal and written communication skills, as well as highly effective presentation and team-interaction skills are necessary.
• Proficiency in Microsoft Office; Argus or Veeva Vault Safety experience is a plus
• Efficient in time management and multi-tasking
• Strong organizational skills, including the ability to prioritize independently with minimal supervision
• An equivalent combination of education and experience may be considered.
• Embody and champion Alector’s values: Act with Integrity. Collaborate. Care.
• Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion. 

Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a treatment, where you’ll drive growth, this is your role. There is no limit to how far you can go with us.

Among the things you’ll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly-lit offices in the heart of the biotech area, flexible remote work options, and competitive compensation and benefits. But these matters only if you’re excited to build and own something great, and tackle these challenges with us. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief. 

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Please click here to apply.