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Post Marketing Pharmacovigilance Operations Sr Manager
Ref No.: 18-12846
Location: Cambridge, Massachusetts
Start Date / End Date: 10/15/2018 to 03/15/2019
Title: Post Marketing Pharmacovigilance (PV) Operations Senior Manager
Duration: 5 Months with possibility for extension
Function: Global Pharmacovigilance

OBJECTIVE:
• The Post Marketing PV Operations Senior Manager is responsible for managing PV operational activities for Client marketed products. This individual role provides a level of expertise, aligned with the principles and standard practices for operational activities related to Post Marketing programs.
• Lead and provide regional insight to global projects where applicable.
• Responsible for Vendor relationships including training, management and agreements related to outsourced post marketing PV activities.
• Partners with key stakeholders within and outside PV to ensure continuous harmonised operations of global PV activities and to maintain high standards for functioning in an integrated environment. Perform root cause analysis and implementation of process improvement strategy to ensure alignment with business objectives.
• Collaborate within and outside PV to ensure continuous harmonised operations of global Pharmacovigilance activities and to maintain highest standards for integrated functioning.

ACCOUNTABILITIES:
• Responsible for representing Global Post Marketing PV Operations in cross-functional meetings and projects related to post marketing operational activities (both internal and external)
• Define, develop and implement processes that link Market Research, Patient Support Programs, IISR studies and post marketing observational programs to post marketing PV operations activities
• Oversight and responsibility for follow-up with reporter/HCP to collect relevant information to complete case assessment per SOPs
• Define the standards and requirements per global regulations and internal processes for reportingof post marketing safety reports
• Responsible for ensuring the collection, processing and evaluation of safety data, development of global SOPs and policies to ensure compliance with regional regulatory requirements and to drive improvements in Client global processes.
• Provide oversight of vendors responsible for post marketing PV activities and be responsible for tracking quality of work per Quality Management Plan
• Responsible for the review of post marketing non-interventional safety sections of study data management plans, agreements and protocols for PV operations
• Liaise with Local Operation Company (LOC) regarding literature monitoring / review and other processes related to Drug Safety Officer (DSO) activities for marketed products
• Provide guidance to the LOC and DSO for all safety responsibilities associated with marketed products
• Responsible for monitoring communication routes for safety case information
• Provide AE Awareness/AE Reporting training for 3rd party vendors, new contract sales staff, or Medical Scientific Liaisons as required
• Oversight and responsibility for global literature searches for investigational and post marketed products
• Ensure ICSR timeline compliance by monitoring workflow reports
• Responsible for collaborating with quality assurance in the collection, exchange, review, identification, and reconciliation of product complaints for potential adverse events
• Responsible for ensuring the safety database is configured to reflect new product, applicable labelling and new post marketing study information for AE collection and processing
• Responsible for compliance with processes for timely reporting and case exchange with applicable parties per safety data exchange agreements
• Responsible for monitoring country approvals and managing processes for timely reporting and case exchange with applicable parties
• Actively provide insight and contribution to the development of standard procedures, processes, applications and methodologies for post marketing PV operations
• Oversight and responsibility for collaboration with Medical Information/Call Center for AE/PC collection and annual training requirements
• Responsible for ongoing exchange or review of data for AE/PCs from market research activities
• Develop, manage and implement special projects as required by management


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• Bachelors required. Degree in scientific/medical field (RN, BSN, Nurse Practitioner, Pharmacist, Physician Assistant) or related experience preferred
• Drug Safety case processing experience highly desirable
• Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for clinical trial and post-marketing environment
• Computer proficiency and computer data entry experience required
• Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment
• Clear, effective written and verbal communication skills
• Ability to work under pressure in order to meet tight deadlines
• Good interpersonal skills (i.e. team player)
• Critical thinking and analytical skills and ability to make high level decisions in cross-functional and global environments.
• Able to interact with personnel from all functional areas and externally to the company at all levels and to represent the department and company in a highly professional manner.
• Good level of computer literacy with Microsoft applications
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously


TRAVEL REQUIREMENTS:
• Some travel to global Client sites may be required.