- 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.
- Collaborate with Quality Assurance to ensure PV compliance in the case of an FDA inspection.
- Support 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.
- 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.
- Bachelor of Science degree, or the equivalent in work experience.
- 5 years of pharmaceutical industry experience, with at least 3 years 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 (CRO's), 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.
- Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting/moving up to 15 pounds (e.g. in order to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and large boxes and files).
- The noise level in the work environment is usually quiet.
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Senior Manager, Pharmacovigilance and Drug Safety - Cambridge, United States - ONO PHARMA USA
Description
This is a Senior Manager level role that oversees the effective delivery of and continued evolution of Pharmacovigilance (PV) activities related to organization's clinical development programs.
Planning and Execution
Financial Outcome
Operation and Improvement
Innovation
Talent Development and Organization Growth
External/Internal Relationship
Educational Requirements
Experience
Technical Skills
Cognitive Skills
Language/Interpersonal Skills
Physical Demands
Work Environment
Business Travel
This role requires the incumbent to travel up to 20% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role. (US Only)
