Drug Safety Consultant

LOCATION: Cambridge, MA – Hybrid (2–3 days in office)

SCHEDULE: Standard EST Hours

DURATION: 12-Month Contract

PAY RATE: $74-79/hr.

Job Responsibilities:

In this role, you will support the Safety Surveillance and Aggregate (SSA) Reports team and manage processes related to global aggregate pharmacovigilance (PV) reports, including PSURs, DSURs, PADERs, and local safety reports.

Key responsibilities include:

· Managing and supporting the development of global aggregate safety reports.

· Serving as a subject matter expert on worldwide aggregate reporting safety requirements.

· Collaborating with Safety, PV Sciences, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external partners.

· Supporting the review and authoring of medical and scientific safety information.

· Working closely with vendors, vendor oversight, and Quality Management teams to ensure high-quality PV documentation.

· Supporting process improvement initiatives to establish compliant, efficient, and consistent global pharmacovigilance processes.

Essential Duties and Job Functions:

· Lead and conduct substantive aggregate reporting projects independently or collaboratively.

· Author and manage PSURs, DSURs, PADERs, and local aggregate safety reports.

· Act as a subject matter expert on global safety reporting requirements, company policies, and aggregate reporting processes.

· Represent aggregate reporting processes in cross-Safety and cross-functional meetings and forums.

· Support the Aggregate Reports Master Schedule, including production, updates, and stakeholder reviews.

· Conduct worldwide legislation reviews related to aggregate reporting requirements.

· Perform impact assessments based on changes in global safety regulations.

· Support the preparation of responses to safety inquiries from health authorities.

· Collaborate with PV Scientists and key stakeholders on regulatory authority responses.

· Drive process improvement initiatives related to aggregate reporting, signal management, clinical trial safety oversight, and ad hoc safety responses.

· Maintain existing pharmacovigilance procedures and support implementation of new PV processes.

· Review and interpret scientific, medical, and safety data and communicate findings clearly.

· Provide guidance on case data evaluation using appropriate clinical judgment.

Knowledge & Skills:

· Strong understanding of pharmacovigilance principles and practices.

· Knowledge of drug development, clinical trial safety, and post-marketing safety regulations.

· Familiarity with case processing, expedited reporting, and safety databases.

· Strong understanding of aggregate safety reporting requirements.

· Ability to interpret and analyze scientific and medical data.

· Strong written and verbal communication skills, including the ability to communicate medical concepts and terminology.

· Strong clinical judgment and ability to evaluate safety information.

· Excellent organizational and project management skills.

· Ability to prioritize multiple projects independently with minimal supervision.

· Strong cross-functional collaboration and interpersonal skills.

· Ability to work effectively with internal teams, vendors, and external stakeholders.

· Proficiency with Microsoft Excel, PowerPoint, and Word.

· Familiarity with Business Objects and common pharmacovigilance safety database systems.

· Strong attention to detail and commitment to quality and compliance.

Education & Experience:

· Bachelor's degree in Biological Sciences, Natural Sciences, or a related field required.

· Advanced degree such as MSc, PhD, MPH, PharmD, or equivalent preferred.

· Minimum of 5 years of pharmacovigilance experience.

· Direct experience writing aggregate safety reports required.

· Experience with safety signal management required.

· Experience with clinical trial and/or post-marketing safety activities preferred.

· Experience working with cross-functional teams in a pharmaceutical, biotechnology, or healthcare environment preferred.

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