Job Description

Location: Cambridge, MA (Hybrid)

Science: Small Molecule

Job Overview: This is a pivotal role within our clients Drug Safety and Pharmacovigilance Operations team, responsible for processing Individual Case Safety Reports and ensuring adherence to SOPs, policies, and regulations across both clinical and post-marketing phases.

Primary Job Responsibilities:

• Provide PV support for clinical studies, streamlining study processes, and collaborating with DSPV and other teams for study deliverables.
• Oversee vendor quality for adverse event processing, case review, and ensure compliance with reporting timelines and reconciliation activities.
• Enhance Drug Safety operations by supporting quality management, compliance monitoring, and maintaining high standards in training and documentation.

Primary Job Requirements:

• Bachelor's in nursing, pharmacy, or life sciences required; Master's or Doctorate preferred.
• Require a pharmacovigilance professional with 3+ years' experience, adept in managing vendor/CRO relationships within the pharmaceutical sector.
• Essential: Global PV experience with ongoing product developments, including expertise in ICSR processes and Safety databases like LSMV/ARISg.
• Must understand ICH GVP and GCP standards, along with FDA/EU regulations and ICH Efficacy guidelines.
• Candidate should have strong analytical and prioritization skills, excellent attention to detail, and the ability to clearly communicate technical data.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

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