Sr. Director, Pharmacovigilance Operations
The Director/Sr. Director, Pharmacovigilance Operation/Drug Safety will be responsible for the core PV operational functions. This includes Case Management, Drug Safety Systems, Alliance and Vendor Management, and Quality Management. This individual will oversee all aspects of adverse event collection, processing and reporting as applicable. They will provide medical and strategic input for adverse event monitoring, coding, and signal detection to ensure that global PV regulatory requirements for case reporting and management are met.
Under the direction of the Head of Drug Safety and Pharmacovigilance, perform signal detection activities, author or contribute to safety sections of investigator brochures, protocols, inform consent forms, and regulatory reports (e.g. PSUR, DSUR, PADER, Annual IND) with focus on providing overview for the medical analysis and safety sections.
The position will report to the Head of Drug Safety and Pharmacovigilance and will work collaboratively within the Drug Safety and Pharmacovigilance department, across departments, and with partner companies to achieve PV and company goals.
- Provide appropriate oversight of the PV vendor performing ICSR collection, processing and reporting activities, including associated quality and training activities to ensure regulatory timelines and global standards are met.
- Support the oversight of the global Pharmacovigilance (PV) system to enable compliance with applicable regulatory PV requirements and guidance.
- Work effectively with Coherus Quality organization and VP of Drug Safety to ensure up-to-date processes and procedures for operational activities in the end-to-end ICSR process.
- Under the direction of the Head of Drug Safety and Pharmacovigilance, perform signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all investigational products
- Participate in safety surveillance strategy and activities for all Coherus' investigational products, including development and implementation of relevant policies and procedures
- Author or contribute to safety sections of clinical investigator brochures, protocols, inform consent forms, CSRs, integrated summaries of safety, core safety information, labels and regulatory reports (e.g. PSUR, DSUR, PADER, Annual IND report; 6-monthly SUSAR line-listings) with focus on providing overview for the medical analysis and safety sections.
- Review and summarize scientific literature relevant to pharmacovigilance on assigned projects
- Support quality management function within PV to ensure compliance with local and international safety requirements and regulatory inspection readiness in collaboration with QA.
- Manage development of Pharmacovigilance agreements (PVAs) and safety exchange agreements (SDEAs) with license partners and distributors in support of PV collaborations.
- Provide expertise on PV operational processes to clinical, developmental and marketing teams, plus other stakeholders, as required. Participate in in inspection readiness activities and preparation as needed
- Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)
- Health care professional degree required (RN, BSN, PA, NP, PharmD or MD)
- Minimum 5-8 years for experience in pharmaceutical safety including a thorough understanding of safety operations and global regulatory requirements, and a broad understanding and/or experience in downstream activities such as signal detection and evaluation as well as risk management activities.
- Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements
- Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.
- Demonstrated experience in managing business process outsourcing vendors and relationships
- Strong team player in a multifunctional, multicultural, growing organization.
- Ability to operate objectively and independently as a leader and as a member of a team, as required.
- Ability to interpret and apply applicable regulations to resolve issues and ability to develop business solutions to complex problems.
- Ability to operate and thrive in a fast-paced environment; demonstrated flexibility, attention to detail and quality focused.
- Strong organizational, project management, technical and problem-solving skills.
- Ability to mentor, and coach within PV and cross functionally.
- Well-developed presentation, communication and interpersonal skills, including strong oral and written communication skills.
- Experience and extensive working knowledge of MedDRA, Proprietary safety databases (i.e.: ARISg, ARGUS), Microsoft Office suite (Word, Excel, PowerPoint)