Senior Safety Scientist Lead, Global Pharmacovigilance

Regulatory Jobs; Boston (MA); On-site; USD 133,000 - 199,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Paid holidays

Health benefits including medical, Rx,

Dental and vision coverage

Job summary

Regulatory Jobs in Boston seeks a Senior Manager, SafetyScientist to evaluate and manage safety risks across product lifecycles, collaborating with GPS Medical Directors and cross-functional teams. The role adheres to global and local GxP standards and AZ procedures within an office setting.

The position covers safety reviews, aggregate reports (PSUR/PBRER/PADER), risk management strategy, and regulatory submissions, with leadership over junior scientists and potential REMS contributions.

Qualifications

• Bachelor’s degree in a biologic/medical/clinical/nursing field with at least 3 years 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.
• Good judgement.
• Ability to interact effectively with colleagues across functions and cultures globally.
• Basic understanding of downstream regulatory, patient, business, and reputational impact of PV actions.
• Office-based role with computer, communication, and collaboration requirements.

Responsibilities

• Contributing to safety data reviews and analyses for products in designated therapeutic areas.
• Authoring or reviewing safety sections of clinical documents (protocols, ICF, IB, SAP, CSR, DMC documents).
• Coordinating and completing high-quality aggregate safety reports (PSUR, PBRER, PADER) for regulatory submissions.
• Overseeing safety for assigned assets, including Safety Strategy and SSaMT/SST.
• Leading program- and study-level safety surveillance and reporting of signal analysis results.
• Authoring and project managing health authority queries.
• Maintaining risk management plans and contributing to REMS documents.
• Assisting GPS Medical Directors in developing risk management strategies.
• Training and/or leading junior safety scientists and fellows.
• Supporting activities related to regulatory filings including eCTD modules and local labels.
• Assisting Global Safety Physicians in safety-related regulatory strategy development.
• Driving timely execution of safety documents and cross-functional engagement; contributing to standardized procedures.
• Representing global patient safety in study teams and cross-functional meetings.
• Contributing to process improvement and cross-departmental consistency.

Skills

Pharmacovigilance knowledge

Analytical skills

Communication skills

Scientific writing

Independence

Judgement

Multicultural collaboration

Education

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

Tools

Power BI

Spotfire

Job description

Regulatory Jobs in Boston seeks a Senior Manager, SafetyScientist to evaluate and manage safety risks across product lifecycles, collaborating with GPS Medical Directors and cross-functional teams. The role adheres to global and local GxP standards and AZ procedures within an office setting.

The position covers safety reviews, aggregate reports (PSUR/PBRER/PADER), risk management strategy, and regulatory submissions, with leadership over junior scientists and potential REMS contributions.