Senior Manager, PV And Drug Safety

Senior Manager, Pharmacovigilance (PV) and Drug Safety

(Onsite a minimum of 3 da

Reporting to the Vice President, PV and Drug Safety, 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.
• This role requires the incumbent to travel up to 20% of the time.