Senior Manager, Safety Scientist

Alexion Pharmaceuticals, Inc.; Boston (MA); On-site; USD 132,000 - 190,000; Full time

Benefits offered by this job

Bonuses

Equity-based awards

Health insurance

Paid time off

Retirement programs

Vision coverage

Job summary

Alexion Pharmaceuticals, Inc. is seeking a Senior Manager, Safety Scientist to evaluate and manage safety risks across the product lifecycle. You will partner with GPS Medical Directors and cross-functional teams from Boston, MA, ensuring compliance with global regulations and AZ procedures.

You will lead safety surveillance activities, author safety sections of clinical documents, coordinate high-quality aggregate safety reports, and mentor junior scientists in a fast-paced office setting.

Qualifications

• Bachelor’s degree in a biologic/medical/clinical/nursing field.
• At least 3 years' experience in drug safety/pharmacovigilance.
• Knowledge of global pharmacovigilance regulations.

Responsibilities

• Contribute to safety data reviews and analyses for products in designated therapeutic areas.
• Author or review safety sections of clinical documents (protocols, ICFs, IIB, SAP, CSR, DMC documents).
• Prepare and complete aggregate safety reports (PSUR, PBRER, PADER) for regulatory submission.

Skills

Analytical skills

Communication skills

Scientific writing

Independence

Cross-functional collaboration

Education

Bachelor’s degree in biologic/medical/clinical/nursing

Tools

Power BI

Spotfire

MedDRA

Job description

The Senior Manager, SafetyScientist plays a pivotal role within Global Patient Safety to actively evaluate and manage safety risks in close collaboration with the GPS Medical Director(s) and cross-functional team members throughout the lifecycle of assigned product(s). You will operate according to the highest ethical, quality and compliance standards as provided by global and local regulations, GxP practice and AZ procedures. You will report to the Director, Safety Scientist, GPS and be based in Boston, MA.

You will be responsible for:

• Contributing to safety data reviews and analyses for products in designated therapeutic areas
• Authoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator’s Brochure, statistical analysis plan, clinical study report, and data monitoring committee documents
• Coordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally
• Ensuring the oversight of safety for assigned assets, including implementation and execution of the Safety Strategy and Management Team (SSaMT) and Safety Surveillance Team (SST)
• Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results.
• Authoring and project management of health authority queries
• Maintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documents
• Assisting GPS Medical Directors in the development of risk management strategy
• Training and/or managing junior safety scientists and fellows
• Supporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information (i.e., CCDS), and local labels
• Assisting Global Safety Physicians in developing a strategy for safety-related regulatory activities
• Proactively managing safety documents by driving timely execution, engaging cross-functional stakeholders, and ensuring adherence to safety governance and regulatory timelines Supporting continuous improvement in safety analytics and reporting by contributing to the development of standardized procedures and templates
• Representing global patient safety as a subject matter expert in clinical study teams and cross-functional meetings
• Contributing to initiatives for process improvement and cross-departmental process consistency
• Maintaining a strong, up-to-date working knowledge of evolving global regulations

You will have:

• Bachelor’s degree in a biologic/medical/clinical/nursing field
• At least 3 years' experience in drug safety/pharmacovigilance
• Knowledge of global pharmacovigilance regulations

• Strong analytical and problem-solving skills

• Excellent communication and interpersonal skills
• Strong scientific writing skills
• Demonstrated learning agility and ability to work independently
• Sound judgementAbility to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
• Basic understanding of downstream regulatory, patient, business, and reputational impact of PV actions
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Nice to have:

• Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD

• Experience preparing aggregate safety reports and conducting signal surveillance

• Experience with clinical development including risk/benefit analysis and safety assessment

• Expertise with clinical and safety databases
• Experience in MedDRA coding and search strategies
• Strong personal time-management and project-management skills
• Experience with data visualization tools (e.g., Power BI, Spotfire)
• Project leadership, organizational, and prioritization skills

The annual base pay ranges from $132K to $190K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.