Sanofi Group Senior Manager - PV Case Management CHC in Bridgewater, New Jersey
The position is the process owner for case management globally in the Company, accountable for group wide alignment of ICSR management standards and processes including receipt, assessment, follow up, data entry, medical evaluation, quality review, distribution and submission within strict internal and regulatory timeframes to deliver quality case data to downstream analysis processes.
Ensure timely compliance to Health Authorities globally for expedited ICSR reporting
Manage the overall processing of ICSRs in the PV database. Thorough, medically-meaningful high quality ICSRs processed within required internal and regulatory timeframes.
Oversee resource allocation, recruitment and training of personnel. Adequate numbers of personnel with background and training appropriate to incumbent and promotional positions.Drive process improvements that support improved compliance, quality and efficiency though adoption of industry-wide procedures.
KEY WORKING RELATIONSHIPS
Oversee participation of case medical evaluators in safety analysis team for input of contextualized case data into the surveillance process and feedback on data requirements. Early Identification and management of potentially-important product safety issues.
This includes oversight of local country, regional, corporate and vendor activities for ICSR processing
Provide platform support for signal activities and GSO activities
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
MD or Pharm D with at least 5 years patient-care experience.
Minimum of 7 years Pharmacovigilance experience including the preparation of Safety Analyses for submission to regulatory authorities.
Knowledge of International Regulatory requirements, thorough knowledge and experience in all aspects of Pharmacovigilance impacted by ICSRs, working knowledge of clinical medical practice and pathophysiology, working knowledge of computer systems and data processing.
Leadership, Teamwork and Management skills;
Good interpersonal and negotiator skills
Strong decision making skills
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.