Associate Director, Clinical Drug Safety

Basic Qualifications

• RN, PhD, PharmD, MS, BS degree in health sciences or related field required.
• 6+ years of experience of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.
• In‑depth knowledge of safety signal identification, evaluation, and escalation processes, including application of governance frameworks and contribution to labeling updates.
• Demonstrated capability in aggregate safety data analysis, ongoing safety surveillance, and risk–benefit assessment for investigational products.
• Experience overseeing and interpreting medical literature surveillance to identify emerging safety information and assess clinical relevance.
• Strong expertise in scientific review and preparation of safety deliverables, including DSURs, line listings, aggregate safety summaries, Investigator’s Brochures, protocols, and regulatory submissions.
• Advanced knowledge of global drug safety/pharmacovigilance regulations, guidelines, and best practices and their application to safety decision making.
• Hands‑on scientific expertise in ICSR and clinical trial SAE assessment, including causality, seriousness, expectedness, and regulatory reportability, with experience guiding SUSAR preparation.
• Proven ability to provide scientific and quality oversight of vendor‑led safety activities, ensuring accuracy, consistency, and regulatory compliance.
• Technical proficiency serving as a drug safety subject matter expert on cross‑functional teams, contributing to safety strategy, complex safety evaluations, and ad hoc scientific analyses.

• Signal Detection and Management
  • Support the implementation of signal identification and management strategy, coordinating discussions within the Drug Safety team and cross‑functional partners.
  • Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational products.
  • Review adverse event data and other safety-related data for signal detection activities.
  • Oversee literature surveillance to identify new or evolving safety information, interpret clinical relevance, and communicate findings as appropriate.
  • Responsible for signaling review and the coordination of signal review activities with Drug Safety and cross-functional teams.
  • Support in the preparation of safety governance slides and documentation of meeting minutes.
• Aggregate reports support
  • Provide scientific input into the preparation and review of aggregate reports such as DSURs and line listings.
  • Oversee DSUR strategy, preparation and adherence to timelines with key cross-functional partners and vendor.
  • Demonstrate effective skills with cross-functional partners to ensure that safety data authorship for aggregate reports such as DSUR are high quality.
• Safety Scientist support during all phases of product development
  • Provide scientific input into the preparation and review of safety‑related sections of protocols, Investigator’s Brochures, and regulatory submissions.
  • Serve as the lead drug safety representative on cross‑functional study teams and in collaboration with senior Drug Safety team, shaping safety strategy, influencing program decision‑making, and advising on safety issue management.
  • Maintain expert‑level knowledge of therapeutic areas and evolving global drug safety regulations, guidelines and best practices, and apply this expertise to support program decision making and safety governance.
  • Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.
• ICSR support
  • Ensure the scientific integrity and quality of safety data through expert review of complex cases.
  • Contribute to case narratives and guide the scientific preparation of regulatory‑ready case submissions, including SUSARs, in alignment with global reporting requirements.
  • Oversee vendor‑led ICSR and clinical trial SAE evaluations, ensuring medical accuracy, regulatory reportability, and global consistency through scientific review and quality governance.
  • Lead or contribute to complex, cross‑functional safety projects, safety signal evaluations, and ad‑hoc scientific analyses to support portfolio needs and organizational priorities.
• Departmental Compliance
  • Ensure drug safety activities remain complaint with evolving regulations.
  • Supporting and assisting in the implementation, execution and maintenance of safety processes.
  • Support initiatives to initiatives for process improvement and consistency.