US_Drug Safety Consultant II

TalentBurst, an Inc 5000 company; Cambridge (MA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Retirement options

Job summary

TalentBurst in Cambridge offers a 12-month Hybrid US_Drug Safety Consultant II role focused on PV aggregate reporting. The candidate will manage PSURs, DSURs, PADERs and local reports, acting as SME for worldwide safety requirements and collaborating with cross-functional teams.

Responsibilities include authoring safety information, coordinating with vendors and QA, driving process improvements, and supporting regulatory responses.

Qualifications

• Bachelor's degree in biological or natural sciences required; Advanced degree preferred.
• 5+ years of Pharmacovigilance experience, including aggregate safety report writing and safety signal management.
• Strong data interpretation and communication skills; ability to present medical data clearly.

Responsibilities

• Serve as SME on worldwide aggregate reporting safety requirements for PV team and cross-functional partners.
• Respond to safety questions and support authoring of medical and scientific safety information.
• Collaborate with vendors and QA to ensure high-quality PV documents.
• Support process improvement and global PV processes.
• Lead and conduct PSURs, DSURs, PADERs, and local reports independently or with others.
• Act as SME on safety requirements and represent processes in cross-functional forums.
• Support Aggregate Reports Master Schedule and annual safety regulatory reviews.
• Assist in authoring regulatory authority responses with PV scientists.
• Drive process optimization to improve consistency in reporting and signal management.
• Maintain existing procedures and support rollout of new PV processes.

Skills

Data interpretation

Cross-functional collaboration

Clinical judgment

Regulatory & PV knowledge

Organization & independence

Technical proficiency

Education

Bachelor's degree in biological or natural sciences

Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred

Tools

Excel

PowerPoint

Word

Business Objects

Job description

Job Title: US_Drug Safety Consultant II; Duration: 12 Months; Location: Hybrid, Cambridge (2-3 days in office)

Position Summary

The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports).

Key Responsibilities

• Serve as a subject matter expert on worldwide aggregate reporting safety requirements for the PV Scientist team, Safety, and cross-functional partners.
• Respond to safety questions from internal and external stakeholders while reviewing and supporting the authoring of medical and scientific safety information.
• Work closely with vendors, vendor oversight, and Quality Management teams to ensure high quality standards across PV documents.
• Support process improvement initiatives in collaboration with PV Sciences and cross-functional groups to develop, implement, and maintain compliant, efficient, and consistent global PV processes.
• Aggregate Report Management: Lead and conduct all aspects of substantive projects, including the authoring and project management of PSURs, DSURs, PADERs, and local reports independently or collaboratively.
• Subject Matter Expertise: Act as an expert on relevant safety requirements, company policies, and aggregate reporting knowledge; represent and articulate processes in cross-Safety and cross-functional forums.
• Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule (production, updates, stakeholder reviews), conduct worldwide legislation reviews for aggregate reporting, and provide impact assessments.
• Health Authority Responses: Support authoring responses to safety inquiries from regulatory authorities alongside PV Scientists and key stakeholders.
• Process Optimization: Drive process improvement initiatives to enhance consistency in aggregate reporting, signal management, clinical trial safety oversight, and ad hoc safety responses.
• Implementation: Maintain existing procedures and support the rollout of new PV processes.

Essential Skills and Qualifications

• Data Interpretation & Communication: Ability to understand, interpret, analyze, and clearly present scientific and medical data verbally and in writing (including medical concepts and terminology).
• Cross-Functional Collaboration: Proven track record of working collaboratively in a team environment across Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external colleagues.
• Clinical Judgment: Ability to apply clinical judgment to interpret case information and guide staff on case data evaluation.
• Regulatory & PV Knowledge: Familiarity with pharmacovigilance, drug development, clinical trial safety regulations, and post-marketing safety regulations (including case processing, expedited reporting, and safety databases).
• Organization & Independence: Strong organizational skills with the ability to prioritize tasks independently with minimal supervision.
• Technical Proficiency: Basic knowledge of standard software (Excel, PowerPoint, Word, Business Objects) and familiarity with common safety database systems.

Education and Experience Requirements

• Education: Bachelor's degree in biological or natural sciences required; Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred.
• Experience: Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.

Benefits and Compensation

• We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

Equal Opportunity Statement

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.