Pharmacovigilance (PV) Scientist

Job Title: Pharmacovigilance (PV) Scientist

Location: Cambridge, MA

Duration: 12 months

Position Type: Full-Time, Hybrid, 40hrs/week

Job Description:

We are seeking an experienced and detail-oriented Pharmacovigilance (PV) Scientist to join our team. This role is integral to ensuring the safety and well-being of patients by contributing to the detection, evaluation, and management of safety signals, as well as the development and application of risk management strategies across the product lifecycle.

The PV Scientist will work collaboratively with safety physicians, study teams, and cross-functional stakeholders to support pharmacovigilance activities and ensure compliance with global regulatory requirements.

Key Responsibilities:

• Collaborate with safety physicians to analyze potential safety issues, including signal detection, evaluation, and management.
• Perform signaling and data mining activities using internal and external data sources (e.g., Empirica, Spotfire).
• Conduct signaling data reviews from various sources, including clinical and safety outputs, literature, and health authority requests.
• Assist in evaluating potential safety issues and quality risk assessment reports using established processes and templates.
• Support safety committees by preparing reports, minutes, meeting documents, and tracking action items.
• Contribute to the authoring of aggregate safety reports (e.g., PSUR, DSUR, line listings) in collaboration with cross-functional leads.
• Develop and edit Safety Management Plans (SMPs) and Emerging Safety Risk Plans (ESRPs), ensuring alignment with regulatory and organizational requirements.
• Provide training and mentorship to new staff on department practices and therapeutic area knowledge.
• Identify gaps in processes and propose improvements to enhance efficiency and compliance.
• Communicate clearly and proactively with cross-functional teams to address and resolve safety-related issues.

Qualifications:

• Degree in a medical or healthcare-related discipline (e.g., MSN, RN, PharmD, Physician Assistant, MD).
• Minimum of 3–5 years of experience in the pharmaceutical industry, specifically in drug safety/pharmacovigilance.
• Strong knowledge of global pharmacovigilance regulatory requirements, including US, EU, LATAM, and APAC regulations.
• Proficiency with safety databases (e.g., Argus, Arisg) and signaling tools (e.g., Empirica, Spotfire).

Preferred Skills:

• Experience in business process improvement methodologies.
• Ability to work in a matrix environment and across diverse geographic areas and cultures.
• Skills in developing and implementing data displays (dashboards) for signaling, compliance, and KPIs/QPIs.
• Demonstrated diplomacy, reasoning, problem-solving, and negotiation skills.

Job Complexity:

• Manage aggregate report activities and Risk Management Plans (RMP) across the product lifecycle.
• Collaborate with cross-functional teams, business partners, and CROs to implement and manage risk management activities.