Associate Director, US Pharmacovigilance and Global Standards - United States
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy.
- Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- Our company is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company.
- Today, we’re doubling down on this goal. Our company Research Laboratories is a true scientific research facility of tomorrow, and will take our company's leading discovery capabilities and world-class small molecule and biologic R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
- Pharmacovigilance (PV) Associate Director is responsible for leading and performing activities associated with inspections and audits involving PV.
- Helps set the strategy for PV and collaborates with members of GCS&PV, GRACS Quality & Compliance and across MRL, MMD and GHH before, during and after the inspection/audit. The PV Associate Director stays current on existing and emerging regulations and guidance pertaining to PV.
- On a continual basis actively works to promote operational excellence by leading the monitoring, developing, and improving of processes related to adverse experience management.
Primacy Activities include but are not limited to:
- Lead in preparing for, facilitating and responding to Health Authority inspections and internal/external audits involving PV
- Develop and collaborate with a network of subject matter experts (SMEs) within GCS&PV and across MRL, MMD and GCP to ensure an ‘inspection ready’ culture
- Collaborate with MRL Quality Assurance and GRACS Quality & Compliance to help set the strategy for the management before, during and after the inspection/audit
- Collaborate with SMEs on the creation of storyboards and fulfilling pre-inspection/audit requests as required
- Participate as on-site facilitator to respond to PV related questions by the inspector/auditor
- Communicate effectively with the inspection/audit support team to ensure requests are being filled accurately and in a timely manner
- Draft inspection/audit responses and ensure Corrective Actions/Preventive Actions (CAPAs) are adequate and consistent across PV and that evidence is provided by due dates
- Provide daily summaries and periodic updates on inspection/audit activities to upper management as required
- Interpret FDA and EU Regulations and ICH Guidelines to ensure compliant case processing globally
- Provide expert guidance on policies and procedures governing the processing of adverse experience information
- Participate and contributes to authoring/reviewing/approving Global Safety Database User Manual, Standard Operating Procedures, and training material as required Liaise with the Data Management Centers and country PV personnel to ensure standardization and optimization of case entry from both a system and process perspective
- Collaborate with and maintain effective working relationships with the global safety community and external customers to ensure compliant adverse experience reporting while also meeting quality standards
Bachelor's degree or master's degree in a life science/ health care/pharmaceutical related field
Candidate is required to have at least 5 years of PV experience, strong working knowledge of PV regulations and safety systems for collection of adverse event information and a proven track record with inspections/audits.
- Candidate should have at least 2 years of experience in leading project teams, proven ability to collaborate across functional groups to drive results and demonstrates leadership with excellent communication and interpersonal skills. Candidate should have ability to identify compliance risks and develop solutions to minimize risk and improve quality management.
- Your role is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.
Travel: Yes, 10 % of the Time