Drug Safety Administrative Manager - Safety Reporting

Cambridge, United Kingdom
26 May 2021
12 Jun 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
The Safety Administrative Manager is responsible for the coordination, management and operation of the safety support staff to support the Pharmacovigilance (PVG) Director, Medical Monitors, Associate Directors, Team Managers, and Safety Specialists. The Safety Administrative Manager coordinates the non-safety/safety aspects of PVG projects and provides technical expertise, coaching/training and guidance to the safety support staff.

The Safety Administrative Manager is responsible for supervising safety support personnel, allocating support resources, and the coordination of safety management responsibilities in accordance with organization goals and objectives for multiple simple/complex, domestic/international studies. The Safety Administrative Manager provides oversight for PVG's triage and Livelink scanning operations, safety hotline after hours answering service, PVG's intranet homepage (including gatekeeping) and space planning/accommodations, equipment/supplies and literary resources for the staff. The Safety Administrative Manager collaborates with PVG operations Senior Management on strategic planning for the PVG division.


Education and Experience:Bachelors Degree in a relevant area4 years experience providing administrative support for clinical trials (or pharmaceutical/clinical research industry experience in PVG, Clinical Operations, Data Management, Regulatory Affairs, or Medical Writing)2 years in a senior/lead/mentoring/supervisory experienceOr equivalent combination of education, training and experience that provides the individual with the required knowledge, skills, and abilities necessary to perform the job Knowledge, Skills and Abilities:Ability to act as a liaison with Senior Management and other Divisions and represent PVG on interdepartmental working groups to achieve corporate directives and goals and their implementationAbility to manage, motivate, mentor and supervise a diverse team and utilize the talents and abilities of all direct reportsProven ability to prioritize and handle multiple tasks simultaneously, to meet rigorous timelines and work effectively in stressful situationsAbility to effectively delegate tasks and follow-up on adequate completionExcellent communication skills including oral, written, and interpersonalKnowledge of medical and safety terminologyExcellent problem solving and decision making skillsDetailed oriented with strong editing skillsExpertise in budget management and metrics and resource allocationsAbility to analyze safety management costs, personnel hours, and project needs to ensure the most cost effective means of safety executionLiaison with Clients and vendors, as needed and provide research metrics for business development initiatives, as neededExcellent knowledge of PPD SOPs, FDA regulations, ICH guidelines, and GCPsProficient in MS Word, MS PowerPoint, MS Excel, MS Access, safety databases and ability to learn other software applications Working Conditions and Environment:Work is performed in an office environment with exposure to electrical office equipmentTravel required on occasionMajority of work computer-basedLong varied hours required on occasionPhysical Requirements:Frequently stationary for 4-6 hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wristsOccasional mobility requiredOccasional crouching, stooping, bending and twisting of upper body and neckLight to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.Ability to access and use a variety of computer software developed both in-house and off-the-shelfAbility to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentencesFrequently interacts with others to obtain or relate information to diverse groupsWorks independently with guidance or reliance on oral or written instructions and plans work schedules to meet goalsRequires multiple periods of intense concentrationPerforms a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrenceAbility to perform under stress and multi-taskRegular and consistent attendancePharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

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