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Senior Manager, Pharmacovigilance and Drug Safety
3 months ago
**Must be willing to work onsite 3 days a week**
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.
- 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.
Planning and Execution
- 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.
Financial Outcome
- Evaluates internal PV processes for added high-performance and efficiencies; determines how the PV organization can positively impact the organization cross-functionally.
Operation and Improvement
- 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.
Innovation
- Identifies process improvements that contribute to the development of the organization’s drug safety strategies.
Talent Development and Organization Growth
- Ensures all internal staff, external consultants and Service Providers are trained to ensure compliance with organization’s SOPs, pharmaceutical industry standards and applicable regulations.
External/Internal Relationship
- Collaborates with leaders and other members of organization’s global pharmacovigilance teams to ensure consistency on the preparation or revision of PV agreements.
Educational Requirements
- Bachelor of Science degree, or the equivalent in work experience.
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.
Technical Skills
- 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).
Cognitive Skills
- Strong analytical, data analysis and problem-solving skills with the ability to review and comprehend statistical data.
Language/Interpersonal Skills
- Excellent communication and presentation skills.
Physical Demands
- 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).
Work Environment
- The noise level in the work environment is usually quiet.
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)
