Manager, Pharmacovigilance 10/8/2017
JOB DESCRIPTIONAPPLY BRIEF DESCRIPTION:
Oversees projects and staff in the Pharmacovigilance Department and responsible for staffing, scheduling, disciplinary actions, evaluations and oversight of pharmacovigilance teams. Assists with budget, change order and invoicing. Responsible for the safety timelines, case quality, meeting client expectations and adherence to regulatory requirements.
SPECIFIC JOB DUTIES:
* Support the Associate Director, pharmacovigilance and the Executive Director/Director, Pharmacovigilance in conjunction with the pharmacovigilance project managers
* Oversee the team safety staff and processes
* Mentor the team safety staff on regulations, processes and client interactions
* Train new hires with UBC safety processes
* Assist in preparation/submission time-and cost-estimates
* Organize the workflow for a given project: establish/keep up to date the tracking sheets, the time sheets, quotations, establish standard texts where appropriate, keep timelines and evaluate compliance, Adverse Event Reporting Plans, and keep an overview of the budget
* Monitor the processes and workflow and implement process improvements
* Process and evaluate AE reports according to the customer s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality assessment
* Participate in Quality Check activities
* Maintain an in-depth knowledge of the relevant drug safety software
* Organize and ensure timely reporting of SAEs
* Ensure documentation any late reports
* Attend client operational Face to Face meetings, Investigator meetings and teleconferences
* Generate and Monitor Team Metrics
* Liaise with the client s responsible persons for assigned projects, and serve as escalation point for issues raised by staff or client
* Prepare procedures, SOPs, guidelines and other standard materials required for program function
* Conduct annual team safety staff performance evaluation, document staff infractions and participate in corrective actions/dismissal decisions
* Monitor staff to ensure compliance and adherence to expectations
* Attend, participate Managers-directors Meetings
* Keep informed about the relevant regulations, legislation and literature of Pharmacovigilance, pharmacology and pharmacoepidemiology
* Inform the Associate Director, Safety and the Executive Director/Director, Safety on relevant issues and potential concerns relating to a product s safety
* Support the preparation of proposals, attend bid-defense meetings
* Participate in relevant seminars and congresses
* Work directly with Human Resources for the ongoing recruitment of resources that are in the Corporate Approved Group Budget
* Senior Safety Scientist, Safety Scientist, Safety Data Manager, Safety Data Associate
* Lead Pharmacovigilance projects and staff
* Medical background: MD, PharmD/RPh, PhD, MSc, Nurse or equivalent
* Solid experience in Pharmaceutical/biotech or CRO Product Safety
* Prior experience in CRO/Pharma/Biotech safety department- minimum of 5 years
* Knowledge of relevant regulation and legislation
* Team/staff management experience preferred
* Fluent in English; additional languages a plus, but not required
* Excellent written and verbal communication skills.
* Excellent interpersonal skills.
* Excellent presentation skills
* Strong computer skills
United BioSource Corporation (UBC) is the leading provider of integrated pharmaceutical support services that optimize global product safety, brand loyalty and patient access on behalf of our manufacturer clients.
UBC s services include Clinical Development & Late Stage Research, Risk Management & Pharmacovigilance, Reimbursement & Patient Assistance, Nursing & Adherence and Product Access & Channel Management. UBC works hand-in-hand with Accredo and CuraScript SD to contract with manufacturers for specialty pharmacy and distribution services.
ABOUT EXPRESS SCRIPTS
Advance your career with the company that makes it easier for people to choose better health. Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes. Join the company that Fortune magazine ranked as one of the \\"Most Admired Companies\\" in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services. We offer a highly competitive base salary and a comprehensive benefits program, including medical, prescription drug, dental, vision, 401(k) with company match, life insurance, paid time off, tuition assistance and an employee stock purchase plan.
Express Scripts is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, national origin, age, veteran status, disability, or any other protected class. Applicants must be able to pass a drug test and background investigation. Express Scripts is a VEVRAA Federal Contractor.