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Sr. Manager, Clinical Science
4 months ago
Quick Facts:
- This company offers a surplus of stability for incoming hires.
- The team is seeking hires who are qualified and ready to hit the ground running.
- Demonstrated and recent (within 6 mo.) case processing experience is a MUST HAVE.
- OPEN TO RELOCATION HIRES
- This role is on-site in Cambridge, MA 3 days a week between the core hours of 10a -3p.
- Must hold US Citizenship or a Green Card.
This Senior Manager-level role oversees the effective delivery of and continued evolution of Pharmacovigilance (PV) activities related to the organization’s clinical development programs.
The Purpose of this Role:
- Develops and designs pharmacovigilance processes and procedures to ensure compliance with regulatory requirements, company objectives and quality standards.
- Evaluates internal PV processes for added high-performance and efficiencies; determines how the PV organization can positively impact the organization cross-functionally.
- Oversees the operational pharmacovigilance (PV) activities that are outsourced to a PV Service Provider (PVSP); ensures the appropriate handling of safety information.
- Collaborates with Quality Assurance to ensure PV compliance in the case of an FDA inspection.
- Supports the cross-functional team i.e. clinical team, Data management team, quality team and regulatory team as required and give inputs and updates as applicable as PV representative.
Responsibilities:
- Develops and designs pharmacovigilance processes and procedures to ensure compliance with regulatory requirements, company objectives and quality standards.
- Collaborates on the pharmacovigilance systems within the organization to achieve globalization of the PV function.
- Evaluates internal PV processes for added high-performance and efficiencies; determines how the PV organization can positively impact the organization cross-functionally.
- Oversees and directly contributes to the operational pharmacovigilance (PV) activities that are outsourced to a PV Service Provider (PVSP); ensures the appropriate handling of safety information.
- Ensures the operational, quality and administrative aspects of Drug Safety.
- Contributes to the development and implementation of risk management plans.
- Identifies process improvements that contribute to the development of the organization’s drug safety strategies.
- Ensures all internal staff, external consultants and Service Providers are trained to ensure compliance with organization’s SOPs, pharmaceutical industry standards and applicable regulations.
- Collaborates with leaders and other members of organization’s global pharmacovigilance teams to ensure consistency on the preparation or revision of PV agreements.
Requirements / Qualifications:
- Bachelor of Science degree, or the equivalent in work experience.
- 5 years of pharmaceutical industry experience, with at least 3 years of safety/pharmacovigilance experience, or relevant clinical development and post-marketing experience within the pharmaceutical, CRO, or biotechnology industry.
- Should be willing to do hands-on work and contribute directly to the projects assigned.
- Experience in the review, evaluation, and interpretation of safety data.
- Experience in preparing SAEs, and authoring individual and aggregate safety documentation.
- Experience managing pharmacovigilance activities and building collaborative relationships with clinical research organizations (CROs), pharmacovigilance Service Providers (PVSP), and vendors.
- Pharmacovigilance safety databases (e.g., ARIS-g, Argus).
- MedDRA terminology and coding.
- International Council for Harmonization (ICH) Efficacy Guidelines, good clinical practice (GCP), and good manufacturing practice (GMP) requirements.
- Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Strong analytical, data analysis and problem-solving skills with the ability to review and comprehend statistical data.
- Excellent communication and presentation skills.
