Manager, Pharmacovigilance

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. 

COMPANY OVERVIEW:

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.

POSITION OVERVIEW:

Disc Medicine is hiring a new Manager of Pharmacovigilance to support the rapid growth of the company’s portfolio. The successful candidate will report to the Director of Pharmacovigilance, and will have direct contact with the clinical, regulatory, data management, and innovations team with meaningful opportunities for professional development and career growth.

RESPONSIBILITIES:

• Review case safety reports received from Clinical Research Organization and/or sites in accordance with SOPs and/ or Study Specific procedures.
• Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of study specific safety systems and processes (as needed).
• Perform Quality Control checks of data entry of cases from safety vendor.
• Assist with oversight of the submissions of expedited and non-expedited safety reports to regulatory authorities, partner companies and other organizations as needed.
• Support the Regulatory and Clinical Operations teams with respect to individual safety related issues, as needed.
• Contribute to the preparation of the clinical sections of annual reports and periodic safety reports.
• Contribute to the development and implementation of drug safety Standard Operating Procedures (SOPs).
• Review and comment on study protocols and associated study documents in regard to individual case reporting.
• Contribute to development and quality control (QC) for key safety documents.
• Contribute to training and oversight of vendors/CRO drug safety staff.
• Contribute as needed to timely review and reconciliation of safety database with clinical database for a given study as needed.
• Oversee and/or implement the generation of queries to the sites for clarification and reconciliation of adverse event reports.
• Ensure timely completion of other safety related tasks as necessary.
• Effectively collaborate with key stakeholders at all levels in the organization including but not limited to, Clinical Operations, Clinical Development, Medical, and Regulatory Affairs to develop compliant procedures in line with industry standards and best practices.

 REQUIREMENTS:

• Bachelors degree in Nursing, Pharmacy or Life Sciences
• Minimum of 5 years of drug safety/pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization (CRO)
• Strong understanding of FDA, ICH, and GCP guidelines as they relate to pharmacovigilance and clinical safety.
• Experience in reviewing and managing case safety reports and overseeing safety data entry and quality control processes.
• Proven ability to collaborate with CROs and vendors for safety case processing and compliance with safety deliverables.
• Familiarity with authoring and reviewing pharmacovigilance documents such as Safety Management Plans, SAE Reconciliation Plans, and periodic safety reports.
• Experience supporting regulatory submissions and knowledge of expedited and non-expedited reporting requirements.
• Ability to participate in and support safety audits, including internal and external/CRO-led audits.
• Strong communication and interpersonal skills, with the ability to represent PV at clinical and cross-functional team meetings.
• Detail-oriented with strong organizational and project management skills, including the ability to manage multiple tasks and timelines in a fast-paced environment.

Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. 

Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.