Drug Safety Manager
Syros Pharmaceuticals is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control expression of disease-driving genes. Syros has built a proprietary platform to systematically and efficiently analyze this unexploited region of DNA in human disease tissue to identify and drug novel targets linked to genomically defined patient populations. Because gene expression is fundamental to the function of all cells, Syros' gene control platform has broad potential to create medicines that achieve profound and durable benefit across a range of diseases. Syros is currently focused on cancer, immune-mediated, and genetic diseases and is advancing a growing pipeline of gene control medicines. Syros' leading drug candidates are SY-1425, a selective RAR agonist in a Phase 2 clinical trial for genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, a selective CDK7 inhibitor with potential in a range of solid tumors and blood cancers. Led by a team with deep experience in drug discovery, development and commercialization, Syros is located in Cambridge, Massachusetts.
The Drug Safety Manager will be responsible for drug safety and risk management activities for Syros Pharmaceuticals, Inc., including clinical trial Serious Adverse Event (SAE) processing, and safety data analysis to support signal detection and risk/benefit profile evaluation. This person will ensure timely, consistent and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). This position is within the Clinical Development Department and reports to the Chief Medical Officer.
Drug Safety representation on study teams for pharmacovigilance activities, including safety updates, safety data review, and meeting participation.
Works with Medical Directors/Safety Physicians, Clinical Scientists, as needed, with safety monitoring activities, including:
Provision of input for responses to regulatory agency questions, and questions from IRBs and Ethics Committees, with respect to safety/pharmacovigilance activities
Investigator's Brochure/informed consent updates
Data analysis (ad hoc, and regular quarterly safety review meetings and monthly safety cohort reviews for ongoing phase 1 dose escalation studies)
Oversees activities with external business partners and vendors (i.e., contract research organizations, data monitoring committees), including non-case related safety and risk management activities, document review/development, aggregate data review, SAE reconciliation, etc.
Leads process development to support case processing, safety reporting, and risk management.
Oversees quarterly safety review of products in development.
Leads the development of and reviews DSURs.
Reviewer for safety sections on cross-functional documents, including study protocols, study reports, and regulatory reports.
Participates in compliance activities related to safety and risk management
Supports audit and inspection activities as needed.
Specific requirements include, but are not limited to:
BS in nursing, pharmacy or life sciences; Master's degree preferred. Minimum of 5+ years in Drug Safety. Clinical trial experience, with demonstrated leadership abilities or roles.
Good knowledge of FDA regulatory requirements for safety reporting.
Good knowledge of EU, ICH and other global regulatory requirements for safety reporting.
Medical knowledge and familiarity with medical terminology.
Ability to multi-task in a fast-paced environment.
Computer knowledge, including Microsoft Office, Windows, and previous safety database use.
Excellence in oral and written communications with attention to detail.
Finally, the candidate will need to embrace our values:
As a team, we:
are committed to transform the lives of patients
are pioneering in our science
challenge each other to achieve excellence
work with passion, integrity and respect
like rigorous work and serious fun
We are not accepting resumes from 3rd party recruitment firms at this time.
Syros Pharmaceuticals, Inc.