Due to continued growth and demand, our Patient Safety Solutions (PSS) group are looking for a Team Leader who will manage and guide PSS staff including performance reviews, human resource issues, and assist Senior PSS Management in assigning resources to projects.
Manage, coordinate and oversee the overall PSS operations associated with the processes for adverse events and expedited safety reports.
to the required standard and ensure submission of them to the client and the regulatory agencies (if required) within the agreed / stated timelines.
The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business.
Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
Duties and Responsibilities :
Responsible for the line-management of individuals within team as well as a project team.
Manage direct reports to ensure staff training records are up to date.
Responsible for managing performance reviews and issues of direct reports.
May manage individuals across multiple teams and will take on responsibility for cross department projects.
Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).
May lead or assist with the management of PSS concerning project allocation and resourcing.
General oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
This includes, but is not limited to, oversight of the following types of tasks :
General oversight for the management and processing of expeditable safety reports (ESRs). This includes, but is not limited to, oversight of the following types of tasks :
Maintain awareness of Covance’s safety database conventions and system functionality.
Maintain awareness of other client safety database conventions and functionality.
May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.
Provide oversight and management of EudraVigilance activities for assigned projects.
Contribute to the generation and review of Time and Cost Estimates for PSS business.
Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.
Prepare and participate in audits, either by the client or a regulatory agency.
Consistently contributes to solving technical and / or operational problems identified by program / project members.
Consistently proposes and executes innovative solutions which influence program / project direction.
Generation of monthly status, staff member performance and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
Effectively draft / modify and deliver safety presentations :
Attend client meetings and liaise with clients where appropriate.
Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
Train new employees overall in pharamcovigilance and regulatory reporting.
Maintain a comprehensive understanding of Covance PSS’ SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
Possess knowledge of all other CDS procedural documents that impact Patient Safety Solutions.
Assist with the generation and review of SOPs, Work Instructions etc.
Responsible for SOP implementation within assigned team.
Assist in developing Operational metrics measuring PSS’ overall performance.
Assist with the recruitment of new staff to Patient Safety Solutions.
Build and maintain good PSS relationships across functional units.
Demonstrate role specific Competencies on consistent basis.
Demonstrate company Values on consistent basis.
Financial authority as it relates to personnel and projects.
Any other duties as assigned by management.
Language Skills Required :
Speaking : English and local language.
Writing / Reading : English and local language.
Experience Required :
Strong relationship-building and interpersonal skills.
Good ability to assess staff performance and propose effective strategies to enhance existing strengths and fill any noted skill or knowledge gaps.
Good ability to propose solutions to effectively address any performance issues.
Ability to provide mentorship and guidance to project support staff.
Ability to grow and develop project support staff through multiple levels within the department career ladder.
Ability to coach project support staff in development of technical skills, efficiency and quality.
Ability to work independently in a staff management capacity, in regular consultation with management.
Ability to perform project review and process analysis, identify potential risks and process improvements and propose appropriate action.
Functions as a positive, engaging and motivating team player.
Ability to direct, manage and coordinate the day-to-day efforts of multiple levels of staff.
Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting.
Ability to effectively manage multiple internal and external customers competing concurrently for attention, services and resources.
Good verbal, written and presentation skills.
Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
Work collaboratively with PSS Management’s team
High degree of accuracy with attention to detail.
Ensure client and global regulatory compliance.
Will present and share useful business information across departments and functions
Anticipate / identify problems and takes appropriate action to correct.
Knowledge of medical and drug terminology
Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
Knowledge of Medical Device Reporting desirable
Knowledge of aggregate reporting desirable
Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
Knowledge of ICH guidelines.
Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
Education / Qualifications / Certifications and Licenses
Minimum Required :
Non-degree + 6-7 yrs safety experience* including 2 years of team leadership experience
Associate degree + 5-6 yrs safety experience* including 2 years of team leadership experience
Associate degree RN + 5-6 yrs safety experience* including 2 years of team leadership experience
BS / BA + 4-5 yrs relevant experience* including 1-2 years of team leadership experience
MS / MA + 3-4 yrs relevant experience (2-3 yrs safety experience) including 1-2 years of team leadership experience
PhD / PharmD + 2-3 yrs relevant experience (1-2 yrs safety experience) including 0-2 years of team leadership experience
For PharmD, a one year residency of fellowship can be considered relevant experience.
Degree preferred to be in one or more of the following disciplines : Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as