Director of Pharmacovigilance Operations - Contract 6-12 Months
The Interim Director of Pharmacovigilance Operations will be accountable for ensuring effective, high quality and efficient management of operational deliverables and strategic planning for departmental needs, to ensure compliance with applicable global regulations and guidelines. This is a contract position
- Under the guidance of senior management, provides strategic planning, implementation, and management of PV's operations activities.
- Works with QA/Compliance to ensure implementation of standardized processes and procedures (SOP) for PV Operations activities to ensure global compliance, including adverse event (AE) and aggregate reporting processes.
- Oversees timeline management and global submission of aggregate safety reports and line listings in collaboration with PV CRO and other key stakeholders as required.
- Assist in the preparation of relevant PV sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents.
- Establishes PV CRO oversight procedures and Key Performance Indicators (KPIs) in collaboration with key stakeholders.
- Assists in ensuring that the PV Database supports the department needs and provides oversight of systems and MedDRA updates in collaboration with the relevant PV CRO.
- Supervises PV operations personnel (direct reports, consultants) including mentoring and training.
- Provides guidance and leadership both internally and externally based on thorough knowledge of safety requirements of clinical trial developmental programs, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP).
- Accountable for identification, development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in PV operations in collaboration with PV CRO.
- Supports training of department personnel and other line functions involved in clinical trial AE collection or processing.
- Provides safety/pharmacovigilance guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials.
- Supports the creation, oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity.
- Facilitates the development and implementation of an inspection readiness program with the contribution of other PV and non-PV stakeholders.
- Supports PV compliance-related investigations, and development and implementation of corrective actions for deviations from case processing procedures, are performed accurately and on time.
- Participates in PV and PV-related regulatory inspections and audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements, including authoring of responses to findings relevant to functional area.
- Provides input in departmental budget planning and management.
- Represents PV as a leader on project teams, other departments, and committees as needed.
- Effectively collaborate with key stakeholders at all levels in the organization. including Clinical Operations, Clinical Development, Regulatory Affairs, Legal and Manufacturing to develop compliant procedures in line with industry standards and best practices.
- At least 5-8 years of experience in global PV for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 4 years of project or line management experience overseeing PV staff and/or consultants/CROs
- Thorough knowledge of FDA and EMA safety regulations, ICH Guidelines, Good Pharmacovigilance Practice (GPvP) and other applicable regulatory guidance documents.
- Bachelor's degree in a health-related field. Advanced degree in life sciences, nursing, pharmacy or medicine, (eg. PhD, PharmD, RN, MD, MPH) a plus.
- Demonstrated ability to prioritize and solve problems with innovative solutions along with strong organizational skills
- Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills
- Effective team player, fosters collaboration within and across functional areas.
- Sound strategic evaluation, analysis, and decision-making skills
- Able to handle pressure in a dynamic, fast paced environment.
- Effectively formulates strategies, tactics and action plans to achieve results.
- Ability to balance competing interests of various stakeholders and strive for achieving mutually beneficial and compliant solutions