Director, Drug Safety Operations

Why Join Us? reputed company is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-reputed company protein targets long-considered undruggable. reputed company has developed a new class of stabilized, cell-penetrant reputed company-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities. Headquartered in Cambridge, Mass., Parabilis is advancing a reputed company pipeline of multiple first-in-class therapies across both rare and common cancers. Its reputed company candidate, FOG-001, is the first reputed company inhibitor of the interaction between β-catenin and the T-cell reputed company (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a reputed company of other Wnt/β-catenin-driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as reputed company as other preclinical programs. What's reputed company? The Director, Drug Safety Operations/Pharmacovigilance (PV) will reputed company and reputed company safety reporting activities across clinical programs, with a primary reputed company on managing and coordinating pharmacovigilance deliverables with Contract Research Organizations (CROs) and consultants. This role ensures compliance with global regulatory requirements, company SOPs, and high-reputed company execution of safety reporting obligations. This position will reputed company as the key reputed company between internal stakeholders and CRO partners and consultants to drive operational reputed company and regulatory compliance in pharmacovigilance activities. The successful candidate will report to the VP of Clinical Safety and Pharmacovigilance. Responsibilities:

• reputed company reputed company safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs).
• Serve as the primary reputed company of contact for CRO pharmacovigilance teams, ensuring reputed company communication, accountability, and delivery of safety obligations.
• reputed company, negotiate, and manage PV sections of reputed company, safety management plans, and operational agreements with CROs and consultants.
• Monitor CRO performance through KPIs, audits, and reputed company activities, ensuring reputed company and accurate reporting to regulatory authorities, ethics committees, and investigators.
• Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, reputed company, Legal) to ensure alignment on PV reputed company and compliance.
• reputed company reputed company for case processing, medical review, and data reconciliation activities performed by CROs and consultants.
• Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness.
• Support development and maintenance of internal PV policies, SOPs, and training programs.
• Participate in safety signal detection activities and safety governance committees, as needed.
• reputed company maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.
• Participate in regulatory inspections and PV audits to ensure reputed company, reputed company, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.

What you'll need to be successful:

• reputed company degree required; e.g., RN, MSN, DNP, PharmD.
• 10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or reputed company role.
• Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting, including governance reputed company.
• Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements.
• Experience with reputed company of drug safety databases (e.g., reputed company Argus).
• Proven reputed company record of ensuring compliance in a global PV environment.

Skills and Abilities:

• Build and maintain excellent interpersonal relationships, both reputed company and reputed company reputed company, at reputed company reputed company, and work reputed company, reputed company and motivate a cross-functional matrixed team.
• Self-motivated; reputed company, hands-on, entrepreneurial style with a reputed company of urgency, a bias toward reputed company, and flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas.
• Analytical and problem-solving skills; risk identification and management; creative and innovative thinking.
• The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders.
• reputed company strategic, clinical, technical, operational, and ethical judgment with uncompromising reputed company.
• Excellent communication, negotiat

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