The PV Manager is responsible for the day-to-day activities and guidance of their PV team members. The PV Manager sets targets, implement guidelines, and assist with any issues the associates may have. Providing leadership and direction, a PV Manager will foster a cohesive, creative, and comfortable working environment, mediating any interpersonal issues within the team. The PV Manager is responsible for developing team members by providing continuous coaching and feedback. They are a catalyst, causing things to happen for other people and stimulating the development of the team through nurturing a climate of trust, respect and shared ownership.
Principal Responsibilities: (Essential Function): Other duties may be assigned.
Accountable/responsible to ensure the timely and accurate processing of Individual Case Safety Reports (ICSRs) for Global Safety Operations, which includes monitoring the adverse event (AE) case processing, adverse event reporting to regulatory authorities, global compliance, inspection readiness, quality management, pharmacovigilance training
Mentor safety staff on regulations, processes and client interactions
Train new hires on safety processes
Organize and monitor processes and workflow
Identify areas for process improvement and implement process improvements as approved by the PV Director
When necessary to ensure department success, process and evaluate AE reports: write the narrative, perform triage of seriousness criteria and causality assessment, as needed
Monitor operations metrics
Participate in quality assessment reviews and audits and prepare appropriate responses to identified findings
Accountable for implementing corrective actions resulting from timeliness or quality issues
Have a working knowledge of budgets, contracts, and service agreements
Participate in analysis of resource requirements to support business initiatives
Subject Matter Expert of the client specific data entry conventions
Assist in the coordination and implementation of the Argus Safety Database validation and User Acceptance Testing
Attend face-to-face meetings and teleconferences, as needed
Assist with establishing Key Performance Indicators (KPIs)
Serve as escalation point for case quality or productivity issues raised by staff or clients
Prepare Standard Operating Procedures (SOPs) and guidelines as required
Monitor staff to ensure compliance and adherence to expectations
Keep informed about the relevant regulations, legislation and literature of Pharmacovigilance
Inform leadership of relevant issues and potential concerns relating to a product’s safety
Support the preparation of proposals
Present at bid-defense meetings
Support executive leadership as needed and escalate relevant and potential issues
Recruit, develop, coach, mentor, and performance manage direct report.
Maintain knowledge, communicate changes, and ensure operational integrity of all policies and procedures
Analyze data, identify performance trends, and take action to improve or sustain performance levels
Consult with appropriate support personnel regarding policy development/implementation, as well as problem resolution (such as data collection/recording-or employee relations issues
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training associates; planning, assigning, and directing work; appraising performance; rewarding and disciplining associates and addressing complaints and resolving problems.
Knowledge of Microsoft Office Suite
Comfortable interacting and making presentations to Directors/VPs at client sites
Financial competencies around sales and profitability
Strong customer focus and orientation
Ability to manage client interactions and influence client decisions
Excellent mentoring and personnel management skills
Ability to read and interpret documents such as safety rules/regulations, standard operating procedures (SOPs) or other job aids.
Ability to write reports, business correspondence and procedure manuals or Standard Operating Procedures.
Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
Minimum of a Bachelor’s Degree or an equivalent healthcare licensure; a minimum of three to five years of experience in a pharmacovigilance environment preferred. Proven success in managing, overseeing or directing staff preferred. Healthcare/Pharmaceutical experience may be required based upon business needs or requirements
C3i Solutions is a world-wide business process outsourcer specializing in the multi-channel engagement of consumers, patients, healthcare professionals and enterprise personnel via a network of global contact centers.
Our unique customer-centric approach has made C3i Solutions the partner of choice for some of the world’s most trusted brands for more than 30 years. C3i Solutions provides unpa...ralleled 24/7 support to customers in over 100 countries speaking 30 different languages.
With strategic focus on innovation and regulatory compliance, C3i Solutions handles more than 35 million interactions per year, helping our clients build and protect their brands while maximizing productivity and cost efficiencies. More than 90 percent of the company’s clients are FDA-regulated.