Annexon Biosciences

Senior Director, Drug Safety and Pharmacovigilance

Annexon Biosciences • $300K — $375K *
San Francisco, CA 94112In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • MD or DO with 8-10 years of drug safety and pharmacovigilance experience in biopharma.
  • In-depth knowledge of global pharmacovigilance regulations, including US and EU guidelines.
  • Familiarity with drug safety databases such as ARGUS.
  • Strong project management, analytical, and problem-solving skills.
  • Ability to adapt and thrive in a fast-paced, growing environment.

Responsibilities

  • Review safety data from all sources during the product development lifecycle.
  • Perform medical assessments of safety-related data for assigned products.
  • Ensure accuracy in case narratives, coding, and medical reviews.
  • Authorize and review sections of aggregate safety reports for quality assurance.
  • Draft responses to health authorities' queries regarding safety issues.
  • Analyze safety data to identify and report potential trends and concerns.
  • Participate in preparation for regulatory inspections and training activities.

Benefits

  • Flexible work schedules and remote work options for work-life balance.
  • Convenient shuttle service from public transportation hubs.
  • Competitive base salary with equity participation and employee stock purchase plan.
  • Comprehensive health benefits package including medical, dental, and vision.
Full Job Description
Position:

The Senior Director, Drug Safety and Pharmacovigilance will work closely with the relevant Medical Monitors and Clinical Development Lead Physician(s) to facilitate signal detection monitoring, product risk-benefit assessment, and safety assessment activities of investigational products within individual clinical programs and - as applicable - across the portfolio. This individual will be responsible for strategic leadership and medical oversight of assigned Annexon product(s) and will report to the VP of Drug Safety and Pharmacovigilance.

Responsibilities include:
  • Reviews all appropriate safety data from various sources throughout the product development lifecycle.
  • Facilitates medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.) for assigned product(s).
  • Ensures accuracy of case narratives, coding and medical reviews and ensures appropriate queries are raised for a comprehensive medical review by relevant company physician(s).
  • Authors/reviews relevant sections of aggregate safety reports and ensures the overall quality of documents.
  • Authors, reviews and provides input as applicable for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator's Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)
  • Responsible for drafting responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues.
  • Lead the analysis, identification and reporting or possible trends and concerns regarding compounds and key related products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety.
  • Participate in the preparation and provision of PV training as needed.
  • Insert bulleted list of core responsibilities [this is not an exhaustive list of tasks]
    • Include any central relationships/collaborations
  • Various other tasks as necessary for the position based on manager's discretion
  • Contribute to and participate in the development and maintenance of a positive team-focused company culture
  • Represent Drug Safety and Pharmacovigilance on DSMBs
  • Participates in inspection readiness activities and preparation as needed.

Education, Experience, and Skills:

Required:
  • Advanced degree in Medicine (e.g., MD, DO) with a minimum of 8-10 years of experience in a Drug Safety and Pharmacovigilance role in a biopharma company.
  • A combination of education and experience that may be deemed appropriate for the position as per the hiring manager and the human resources team's discretion
  • A thorough understanding of the global pharmacovigilance regulatory environment with working knowledge of US and EU regulations (e.g. MedDRA, WHODRL), ICH guidelines, and a working understanding of drug safety databases (e.g. ARGUS), effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
  • Flexibility and agility to function on various levels of the role as required in a fast-growing environment.
  • Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.

Preferred:
  • Experience filing submissions for marketing authorization
  • Medical knowledge with the ability to interpret, synthesize, and communicate complex safety data.

Salary Range: $300,000 - $375,000

Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.

Benefits:
  • A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
  • Shuttle service from BART, CalTrain and the Ferry.
  • Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

About Annexon Biosciences

Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The company's pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of product candidates into clinical development, including its lead program, ANX005, for the treatment of Guillain-Barré Syndrome and Warm Autoimmune Hemolytic Anemia. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated exposure level, enabling the company to continue development with a high level of confidence in its approach.
Learn more about Annexon Biosciences
Size
30 employees
Market Cap
$917
Industry
Pharmaceuticals & Biotech
Founded
2011
NASDAQ
ANNX
* Ladders Estimates
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