Associate Director of PV Operations
3 weeks ago
As the Associate Director of PV Operations, you will be responsible for developing and overseeing the execution of PV processes and deliverables performed internally, contracted independent consultants, and/or vendors. This role will support the PV infrastructure with PV operational activities such as management and support of the relationship with safety vendors to ensure effectiveness, quality, and compliance of outsourced activities and support departmental budget adherence and other budget-related KPIs.
Key Responsibilities- Improve/standardize the set-up of new safety projects, vendor management (working with internal and external colleagues including Quality Assurance and Sourcing, as needed)
- Manage the process for identifying, evaluating, selecting, and managing outsourcing vendors involved in safety activities (including regular auditing/requalification and training)
- Responsible for setting up a collaborative working relationship with suppliers and vendors to ensure regulatory requirement compliance
- Maintain oversight of adherence to contractual agreements
- Develop/oversee execution of PV processes and deliverables performed internally, contracted independent consultants, and/or vendors to ensure compliance/alignment with regulatory requirements and internal policies/procedures
- PV Budget activities and management with a strong collaboration with colleagues across the organization (PV, Medical Affairs, and Finance)
- Assist in monitoring industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommend changes and upgrades to existing departmental policies, SOPs, and systems
- Perform a variety of activities within the safety organization, including but not limited to monitor and maintain compliance, provide technical expertise, and working cross-functionally with team members and externally with partners and CROs
- PV Audit and inspection participation, CAPA management, and collaboration with PV Compliance team. Helps to coordinate the audit process of business partners, CROs, and vendors
- Awareness of best practices across PV, including manage process improvements and commitment to Lean methodologies and activities
- Bachelor's degree required, Master's preferred
- Minimum of 6 years of pharmaceutical/biotechnology industry experience, including at least 2 years PV operations, budget management
- Knowledge of US/EU/AP/LA regulations and ICH guidelines
- Exposure to working relationship with FDA and other regulatory authorities
- Experience working with third-party vendors
- Understanding of pharmacovigilance-related information systems
- Proficiency working in Windows-based work processing and experience with medical/scientific/regulatory databases/resources
- Must be permitted to work in the USA with the ability to travel domestically and internationally (up to 10%)
- Global experience preferred
- High integrity, sense of urgency, ability to recognize time sensitivity, willingness to work in a matrix environment, and assume the role of player/coach as necessary
- Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, excellent analytical, negotiating, and influencing skills
- Budget tracking experience, as well as demonstrated vendor oversight
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