Associate Director of PV Operations
4 weeks ago
At Lifelancer, we are seeking an experienced Associate Director of PV Operations to join our team. As a key member of our Pharmacovigilance (PV) department, you will be responsible for developing and overseeing the execution of PV processes and deliverables.
Key Responsibilities:- Develop and implement PV processes and deliverables to ensure compliance with regulatory requirements and internal policies.
- Manage the relationship with safety vendors to ensure effectiveness, quality, and compliance of outsourced activities.
- Collaborate with internal stakeholders to ensure adherence to contractual agreements and departmental budget.
- Monitor industry best practices and changes in global safety regulations and guidelines, and recommend updates to existing departmental policies and systems.
- Perform a variety of activities within the safety organization, including monitoring and maintaining compliance, providing technical expertise, and working cross-functionally with team members and externally with partners and CROs.
- Bachelor's degree required, Master's preferred.
- Minimum of 6 years of pharmaceutical/biotechnology industry experience, including at least 2 years of PV operations and budget management.
- Knowledge of US/EU/AP/LA regulations and ICH guidelines.
- Experience working with third-party vendors and regulatory authorities.
- Understanding of pharmacovigilance-related information systems and proficiency in Windows-based work processing.
- Global experience preferred.
- High integrity, sense of urgency, and ability to recognize time sensitivity.
- Excellent written and verbal communication skills, exceptional listening skills, and strong presentation skills.
- Budget tracking experience and demonstrated vendor oversight.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains. Please use the below Lifelancer link for job application and quicker response.
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