Senior Director, Drug Safety and Pharmacovigilance
Annexon Biosciences
16 days ago
Remote friendly (San Francisco Bay Area)
United States
Medical Affairs
Position: Senior Director, Drug Safety and Pharmacovigilance
Responsibilities:
- Review safety data from various sources throughout the product development lifecycle.
- Facilitate medical assessment of safety data (AEs, SAE, SUSAR, AESI, etc.) for assigned products.
- Ensure accuracy of case narratives, coding, and medical reviews; raise appropriate queries for comprehensive medical review by company physicians.
- Author/review relevant sections of aggregate safety reports and ensure document quality.
- Author/review/provide input for drug-safety regulatory reports and clinical study documents (Clinical Study Protocols, Informed Consent Forms, Investigator’s Brochures, ISS, MedDRA coding, product labeling, CCSI).
- Draft responses to regulatory and healthcare professional queries on safety and related legal questions.
- Lead analysis and reporting of potential trends/concerns; identify and evaluate safety signals via single case reports, aggregate safety reports, and relevant literature.
- Participate in PV training preparation/provision as needed.
- Contribute to a positive, team-focused company culture.
- Represent Drug Safety and Pharmacovigilance on DSMBs.
- Participate in inspection readiness activities as needed.
Education/Experience/Skills:
Required:
- MD/DO or advanced medical degree; 8–10+ years in Drug Safety and Pharmacovigilance in a biopharma company.
- Understanding of global pharmacovigilance regulations (US/EU), ICH guidelines, MedDRA/WHODRL, and drug safety databases (e.g., ARGUS); strong project management, critical/timely insight, and analytical problem-solving.
- Flexibility/agility in a fast-growing environment.
Preferred:
- Experience filing marketing authorization submissions.
- Medical knowledge to interpret/synthesize/communicate complex safety data.
Benefits:
- Flexible work schedules, remote opportunities, work-life balance.
- Shuttle service from BART, CalTrain and the Ferry.
- Competitive base salary and equity; employee stock purchase plan; comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans).
Salary Range: $300,000 - $375,000
Location: Brisbane, CA (preference for San Francisco Bay Area candidates).
Responsibilities:
- Review safety data from various sources throughout the product development lifecycle.
- Facilitate medical assessment of safety data (AEs, SAE, SUSAR, AESI, etc.) for assigned products.
- Ensure accuracy of case narratives, coding, and medical reviews; raise appropriate queries for comprehensive medical review by company physicians.
- Author/review relevant sections of aggregate safety reports and ensure document quality.
- Author/review/provide input for drug-safety regulatory reports and clinical study documents (Clinical Study Protocols, Informed Consent Forms, Investigator’s Brochures, ISS, MedDRA coding, product labeling, CCSI).
- Draft responses to regulatory and healthcare professional queries on safety and related legal questions.
- Lead analysis and reporting of potential trends/concerns; identify and evaluate safety signals via single case reports, aggregate safety reports, and relevant literature.
- Participate in PV training preparation/provision as needed.
- Contribute to a positive, team-focused company culture.
- Represent Drug Safety and Pharmacovigilance on DSMBs.
- Participate in inspection readiness activities as needed.
Education/Experience/Skills:
Required:
- MD/DO or advanced medical degree; 8–10+ years in Drug Safety and Pharmacovigilance in a biopharma company.
- Understanding of global pharmacovigilance regulations (US/EU), ICH guidelines, MedDRA/WHODRL, and drug safety databases (e.g., ARGUS); strong project management, critical/timely insight, and analytical problem-solving.
- Flexibility/agility in a fast-growing environment.
Preferred:
- Experience filing marketing authorization submissions.
- Medical knowledge to interpret/synthesize/communicate complex safety data.
Benefits:
- Flexible work schedules, remote opportunities, work-life balance.
- Shuttle service from BART, CalTrain and the Ferry.
- Competitive base salary and equity; employee stock purchase plan; comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans).
Salary Range: $300,000 - $375,000
Location: Brisbane, CA (preference for San Francisco Bay Area candidates).