Position SummaryThe Senior Director, Safety & Pharmacovigilance will provide strategic and operational leadership for Larimar's global drug safety and pharmacovigilance activities across the product lifecycle, from clinical development through commercialization and post-marketing surveillance.
This role will have overall responsibility for maintaining, and continuously improving a robust, scalable, and inspection-ready pharmacovigilance system that meets applicable global regulatory requirements and supports the company's clinical, regulatory, and commercial objectives.
As the company's senior pharmacovigilance subject matter expert, the Senior Director will provide relevant strategic guidance to executive management and cross-functional teams; oversee safety surveillance, signal detection and evaluation, aggregate safety reporting, safety and pharmacovigilance systems, and pharmacovigilance vendor performance; and ensure appropriate identification, assessment, escalation, and mitigation of emerging safety risks.
The successful candidate will be a highly collaborative strategic leader who can operate effectively in a growing biotech environment, build fit-for-purpose capabilities, and translate complex safety information into clear recommendations and decisions for senior leadership.
Key Responsibilities:- Serve as the senior subject matter expert and strategic leader for safety and pharmacovigilance, executing pharmacovigilance-related and associated tasks in support of multi-disciplinary department activities.
- Execute and refine the company's global pharmacovigilance strategy in alignment with clinical development, regulatory, medical, quality, and commercial objectives.
- Maintain and improve a comprehensive, scalable pharmacovigilance system and safety operating model consistent with applicable global laws, regulations, and industry guidance.
- Support and maintain appropriate safety governance, processes, standards, and procedures to support a compliant, effective, and inspection-ready pharmacovigilance function.
- Provide day to day oversight of pharmacovigilance vendors and perform review and assessment of individual case safety reports, aggregate safety data, and queries.
- Lead signal detection, validation, evaluation, and management activities and ensure timely escalation of significant safety findings.
- Conduct and oversee clinical safety and benefit-risk assessments and recommend appropriate risk mitigation strategies.
- Partner with Clinical Development, Biostatistics/Statistics, Data Management, Medical, Regulatory, and other functions to ensure integrated evaluation of clinical safety data.
- Ensure appropriate maintenance and oversight of the clinical safety database and associated safety data processes.
- Ensure compliance of the global pharmacovigilance system with applicable FDA, EMA, ICH, and other relevant international regulatory requirements and guidance.
- Provide relevant content for regulatory submissions, agency interactions, and other regulatory activities.
- Support regulatory inspections and ensure ongoing inspection readiness for pharmacovigilance activities, systems, processes, and vendors.
- Monitor evolving regulatory requirements and industry standards and proactively assess their impact on the company's safety strategy and operations.
- Partner with Quality, as appropriate, on vendor qualification, audits, performance management, and issue resolution.
- Provide safety input into clinical development strategy, protocols, informed consent materials, study plans, and other relevant development activities.
- Represent Safety & Pharmacovigilance in corporate due diligence activities, including potential acquisitions, licensing opportunities, partnerships, and other strategic transactions.
- Oversee the development, execution, and maintenance of Safety Data Exchange Agreements and other pharmacovigilance agreements associated with development, licensing, commercialization, and distribution partnerships.
- Provide strategic safety input into preparation for FDA Advisory Committee meetings and other significant regulatory milestones, as applicable.
- Foster a culture of proactive risk identification, scientific rigor, regulatory compliance, and patient safety.
- Perform other duties and strategic initiatives as appropriate to support the company's objectives.
Requirements
Required- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related scientific discipline.
- 10+ years of progressive experience in pharmacovigilance and drug safety within the biotechnology or pharmaceutical industry.
- Significant experience leading global pharmacovigilance programs across clinical development and/or post-marketing environments.
- Demonstrated expertise in safety surveillance, signal detection and management, aggregate safety reporting, benefit-risk assessment, and clinical risk management.
- Strong knowledge of applicable global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, and other relevant health authorities.
- Working knowledge of electronic data capture systems and pharmacovigilance software
- Experience developing, implementing, and maintaining pharmacovigilance systems, processes, and quality standards.
- Experience managing CROs and other external pharmacovigilance service providers.
- Demonstrated ability to provide strategic safety advice and influence decisions at the senior leadership level.
- Experience working effectively in cross-functional teams within a complex, fast-paced biotech or pharmaceutical environment.
- Strong written, verbal, analytical, organizational, and interpersonal skills.
- Demonstrated ability to balance strategic leadership with hands-on execution in a growing organization.
Preferred- Advanced degree (M.S., Pharm.D., M.D., Ph.D., or equivalent) in a relevant scientific or clinical discipline.
- Experience supporting a product through regulatory approval and into commercialization.
- Experience establishing or significantly scaling a pharmacovigilance function within a growing biotech organization.
- Experience supporting FDA Advisory Committee meetings or other significant regulatory milestones.
- Experience with due diligence, licensing, business development, or strategic partnerships.
- Experience with combination products, biologics, medical devices, or other complex product modalities.
- Relevant pharmacovigilance certifications or specialized training.
