Drug Safety Manager

Syros Pharmaceuticals, Inc.

Cambridge , MA 02138

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.

Key Responsibilities:

  • 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.

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If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information. Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest. Shire Cambridge MA

Drug Safety Manager

Syros Pharmaceuticals, Inc.