Pharmacovigilance Manager - Safety Reporting

at  Thermo Fisher Scientific

JOB DESCRIPTION

Join Thermo Fisher Scientific Inc. as a Pharmacovigilance Manager and be at the forefront of ensuring patient safety in an outstandingly collaborative and innovative environment. This is an outstanding opportunity to support to exceptional research initiatives and work with a team dedicated to making a global impact.
Job Responsibilities
Discover Impactful Work:
Coordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior management and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team

A day in the Life:

• Monitors, evaluates, and proposes mitigation strategies surrounding risk to PV project deliverables and finances.
• Serves as Key point of contact for client.
• Accountable for project financial stewardship and participates decision-making for options with the client for various increases in scope of work to drive healthy gross profit and revenue margins.
• Drives timelines and tasks/results for safety reporting PV functions
• Prepares and leads operational/tactical/governance calls with client(s).
• Coordinates and leads preparation and attendance in client audits/inspections.
• Maintains effective communication and coordination with other functional groups concerning project topics/issues.
• Coordinates generation of project metrics (e.g., key performance indicators, volumes, etc.).
• Maintains budget/financial oversight of assigned project(s), working with applicable teams for contractual activities (i.e., change notification forms, contract modifications, renewals, etc.) for all PV services.
• Responsible for internal financial and project review meetings.
• Accountable for collaboration with all PV functions to ensure critical metrics meet agreed targets.
• Leads departmental initiatives.

Education

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification to include 3+ years of safety experience
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
• 1+ year of leadership responsibility

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

• Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to relevant legislation/regulations/guidance, global SOPs and client expectations
• Broad understanding of PV along with working knowledge of the global regulatory requirements and the importance of procedural/process compliance
• Proficient in Microsoft Office products and safety databases
• Good command of English and ability to translate information into local language where required
• Excellent oral and written communication skills
• Strong attention to detail and accuracy
• Strong critical thinking, problem solving and decision-making skills

Please refer the Job description for details