PV Strategy Manager
Hendre Moolman at CK Clinical is recruiting for a Drug Safety Strategy Manager to join a global pharmaceutical company at their site based in Hertfordshire on a permanent basis.
Your main responsibilities in this role will be to:
- Define and maintain the audit of PV processes and activities, and perform risk assessment to determine annual audit plan; define and maintain risk assessment methodology and related procedures and tools
- Assess data metrics from PV audits, inspections, regulatory intelligence and risk management activities by the business functions for compliance trends and risks; develop communication tools for audits and inspection metrics and trends
- Define audit scope for internal process and licensing partner audits, review audit plan, audit reports which contain a PV component, and assist evaluation of CAPA as assigned;
- Act as a point of contact for internal process PV and licensing partner audits and support the lead auditor
- Participate in PV audits, and support regulatory authority PV inspections
- Maintain highest level of awareness, expertise in international PV regulations and internal policies and SOPs;
- Assess impact of new regulations and guidance on PV activities
- Provide quality leadership and direction to PDQ/PDQA and our customers/stakeholders on PV related issues;
- Establish strong partnership with key stakeholders in business functions and represent PDQ/PDQA in cross-functional governance teams
- Participate in or lead department or cross-functional compliance projects and initiatives as assigned;
You are required to have the following qualifications, skills and experience:
- Bachelor's degree or equivalent in scientific or quality-related field with significant experience in pharmaceutical industry and/or quality assurance.
- Proficiency in the conduct of PV audits is desired.
- Experience in pharmacovigilance, with demonstrated applied knowledge of pharmacovigilance and international pharmacovigilance regulatory requirements and guidance
- Experience in compliance program or project management, with demonstrated analytical, organizational and planning skills
- Proven demonstration of leadership, strategic and system thinking
- Demonstrated problem solving and decision-making skills
- Ability to work effectively in an international multicultural matrix organization; highly effective team work and collaboration skills
- Demonstrated ability to effectively communicate, influence and lead both with and without authority; fluency in written and spoken English
If you are employed by this client you will be joining a global pharmaceutical company based in Hertfordshire. Other benefits include:
- Competitive salary
- Car allowance with a competitive company bonus
For more information or to apply for this Drug Safety Strategy Manager position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process. Entitlement to work in the EEA is essential. Please quote reference CL31450 in all correspondence.