Job Description
Pay: $79.62/Hour
Duration: 1 year
Location: Hybrid, Cambridge (2-3 days in office)
*Must have strong aggregate report authoring experience*
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
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.
Qualifications:
Duration: 1 year
Location: Hybrid, Cambridge (2-3 days in office)
*Must have strong aggregate report authoring experience*
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).
- 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.
Key Responsibilities
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.
Qualifications:
- Bachelor's degree in biological or natural sciences required; Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred.
- Minimum of 5 years of Pharmacovigilance experience, including direct experience in aggregate safety report writing and safety signal management.
- Ability to understand, interpret, analyze, and clearly present scientific and medical data verbally and in writing (including medical concepts and terminology).
- Proven track record of working collaboratively in a team environment across Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external colleagues.
- Ability to apply clinical judgment to interpret case information and guide staff on case data evaluation.
- Familiarity with pharmacovigilance, drug development, clinical trial safety regulations, and post-marketing safety regulations (including case processing, expedited reporting, and safety databases).
- Basic knowledge of standard software (Excel, PowerPoint, Word, Business Objects) and familiarity with common safety database systems.
Numbers & Facts
| Location | Cambridge, MA |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Skills
- Advertising Monitoringunmatched
- Analysis Skillsunmatched
- Biologyunmatched
- Clinical Monitoringunmatched
- Clinical Practices/Protocolsunmatched
- Clinical Trial Managementunmatched
- Communication Skillsunmatched
- Corporate Policiesunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Database Technologyunmatched
- Drug Developmentunmatched
- Marketingunmatched
- Master Production Scheduleunmatched
- Medical Affairsunmatched
- Medical Writingunmatched
- Medical and Scientific Writingunmatched
- Microsoft Excelunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Natural Scienceunmatched
- Pharmacovigilanceunmatched
- Process Improvementunmatched
- Process Managementunmatched
- Project/Program Managementunmatched
- Quality Metricsunmatched
- Regulationsunmatched
- Reporting Skillsunmatched
- SAP BusinessObjectsunmatched
- Safety Systemsunmatched
- Safety Trainingunmatched
- Surveillanceunmatched
- Team Playerunmatched
- Vendor/Supplier Quality Managementunmatched
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