Job Details

Company: United BioSource Corporation.
Location: Philadelphia, PA
Reference: REQ20010869
Closing Date: 19 May 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

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. ...

Requirements:

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

Supervisory Responsibilities:

• Senior Safety Scientist, Safety Scientist, Safety Data Manager, Safety Data Associate
• Lead Pharmacovigilance projects and staff

Requirements:

• 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

About UBC

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety. While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management.

Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.

By combining insight from data, understanding patient behavior, and the science behind clinical specialties, we can help our clients make informed decisions and optimize the care given to patients using their therapies and products.

*LI-CD1-UBC