Mgr, Drug Safety for i3 Drug Safety in Cary, NC

UnitedHealth Group is an innovative leader in the health and well-being industry, serving more than 55 million Americans. Through our family of companies, we contribute outstanding clinical insight with consumer-friendly services and advanced technology to help people achieve optimal health.

The Pharmacovigilance Manager is responsible for training, managing and evaluating Pharmacovigilance staff. Ensuring that safety reports are processed and reported according to ICH-GCP guidelines, regulatory requirements and i3 research SOPs or procedures agreed with the Sponsor. Responsible for the set-up of all studies.



Manage the day to day running of the Pharmacovigilance Department by:
1. Designing and planning the work strategy of the Pharmacovigilance Department.

2. Implementing this work strategy by delegating tasks to members of the Pharmacovigilance Department.

3. Monitoring and managing the daily activities of members of the Pharmacovigilance Department including authorising holidays and performing appraisals.

4. Organising and giving training sessions for project teams and other members of the Pharmacovigilance Department to ensure quality of all safety data.

5. Designing and implementing procedures to ensure the smooth running of the Pharmacovigilance Department. e.g. ensuring the accuracy and completeness of safety information entered on the SAE tracking system and compiling safety reports for submission to regulatory authorities.

6. Oversee the set-up of all new studies including the preparation of sponsor specific SAE processing documents (Safety Monitoring Plan) for potential sponsors and presenting these plans at client meetings.

7. Assist Business Development in all safety related issues required for the preparation of proposals/ contracts for potential sponsors. This involves participation in teleconferences and helping with presentations.

8. Perform other related duties as assigned or requested by the Senior Director of Regulatory Affairs & Pharmacovigilance.


The postholder will perform necessary functions and as directed, any other duties commensurate with the post to ensure the smooth running of operations within the location(s).

This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the postholder.






Job Requirements:

Attention to detail Able to identify and resolve discrepancies on SAE reports and case report forms. Notes and resolves errors in written documentation
Communication, verbal Conveys thoughts in a clear, concise, and accurate manner. Uses correct grammar. Listens carefully and asks questions when necessary to ensure understanding.
Communication, written Conveys findings in a clear, concise, and accurate manner.
Computer literacy Uses required computer hardware and software as productivity tools in performing work-related tasks. Able to enter information into company-required tracking programs with occasional outside assistance.
Customer service Establishes and maintains effective relationships with customers (clients and site personnel) and gains their trust and respect. Provides customers with complete and accurate information. Obtains first-hand customer information and uses it to improve the delivery of the service. Follows through on commitments made. Maintains a high energy level when interacting with customers. Demonstrates professionalism and presents a positive image of the company. Acts with the customer in mind.

Development of self and others Identifies personal career development goals and opportunities related to current job. Seeks additional training and takes responsibility for completing assigned training. Solicits and applies performance feedback.
Planning & organizing Advise team members on all project specific issues. Prioritizes time effectively based on project needs. Consistently meet deadlines. Seeks management input with any difficulties in establishing priorities. Able to track compliance with study timelines. Plan company travel efficiently and cost-effectively and meet achievement expectations for the trip.
Problem solving & decision making Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
Relationship building Maintains positive relationships with site personnel, clients and colleagues. Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
Technical knowledge Developing knowledge of protocol, regulatory requirements, company SOPs. Familiar with team structure and phases of research. Able to identify and document protocol violations, regulatory non-compliance, and any issues involving subject safety. Often requires input from management in resolving these issues.
Therapeutic knowledge Developing knowledge of the disease under study. Able to discuss simpler aspects of the disease process with site personnel and colleagues.
Work habits Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties. Consistently meets deadlines.



Qualifications:
-Bachelor's level degree in life sciences, pharmacy, nursing or RN, or equivalent clinical research experience
-Minimum of 4-5 years of experience in Pharmacovigilance
-Apply SOP's and CA regulations pertaining to Pharmacovigilance
-Establish effective relationships with sponsors, as well as team members
-Ability to successfully prioritize and work on multiple tasks
-Effective written communication skills
-Computer proficient
-Must have a minimum of 2 years supervisory experience.
-Ability to establish effective relationships with sponsor and team members
-Ability to successfully prioritize and work on multiple tasks
-Knowledge of specific study therapeutic areas
-Effective written communication skills