Senior Director, Drug Safety and Pharmacovigilance

Responsibilities

• 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.
• 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

• 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 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.
• Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.

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.
• 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.

Qualifications

• Flexibility and agility to function on various levels of the role as required in a fast-growing environment.

Skills

• Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.

Requirements

• Advanced degree in Medicine (e.g., MD, DO).
• Minimum of 8-10 years of experience in a Drug Safety and Pharmacovigilance role in a biopharma company.
• 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.

Pay

$300,000 - $375,000

Schedule

Full-time

Benefits

• A comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

Company Culture

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.