• Supervision and coordination of following activities:
• Lead and manage the project to comply with the SOW and SLAs.
• Supervise all project related activities.
• Single point of contact between the team and the client for smooth functioning of the project.
• Communicate between the management and the team.
• Record, maintain and track the metrics for both team members and project performance.
• Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
• Process current incoming cases in order to meet timelines.
• Provide guidance for Data entry.
• Following up with sites regarding outstanding queries.
• Follow-up on reconciliation discrepancies.
• Follow departmental AE workflow procedures.
• Train and mentor new team members as per requirements of the project.
• Act as a management level liaison between Client and Bioclinica Project team
• Coordinate and manage administrative project issues
• Delegate tasks and responsibilities to appropriate personnel
• Identify and resolve issues and conflicts within the project team
• Recruit select and train team members
• Act as guide, coach and counselor for the team
• Following up with sites regarding outstanding queries and reconciliation of discrepancies
• Closure and deletion of cases
• Follow departmental AE workflow procedures
• Oversee, mentor and guide the activities of the Drug Safety and Senior Drug Safety Associates
• High level of proficiency at all workflow tasks
• Perform any other drug safety related activities as assigned
• Subject Matter Expertise in Safety database
• Proven experience in customer handling and relationship.
• Proven ability to perform task management.
• Proven People management skills.
• Must have good presentation skills and the ability to give presentations.
• Knowledge of the Life Sciences Industry a plus.
• Experience in entire drug development life cycle.
• Relevant product and industry knowledge
• Experience with relevant safety databases and software applications
Education: Any Healthcare professional (B pharm / M pharm / Pharm D or any other equivalent qualification)
Experience: 5-6 years of experience in Pharmacovigilance
• Strong motivational skills and abilities, promoting a team-based approach
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Ability to maintain professional and positive attitude
Travel: 0-50% (can be adjusted)
Lifting: 0-50 lbs. (can be adjusted)
Other: Computer work for long periods of time
THIS JOB DESCRIPTION SHOULD NOT BE DEEMED ALL-INCLUSIVE.ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED.AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.
Bioclinica is an equal opportunity employer.Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
Bioclinica is an integrated clinical life science solutions provider, delivering powerful insight into clinical trial development, assuring greater client success in bringing medical therapies to market for people around the world. Through deep medical, scientific, and technology expertise, Bioclinica provides medical imaging and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments; clinical trial management software; and drug safety solutions. Bioclinica’s global team of life science experts serve more than 500 pharmaceutical, biotechnology, and device organizations – including the top 20 biopharmaceutical companies and leading CROs – through locations in North America, Europe, and Asia.