Job Overview
Line manage PSS staff including performance reviews, human resource issues, and assist Senior PSS Management in assigning resources to projects. The post holder is typically, but not exclusively, responsible for providing line management of junior PSS staff. 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. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Summary Of Responsibilities
Global PVA/SLA/ICA Management
- Maintenance of PVAs/SLAs/ICAs through their review cycle and update according to upcoming needs.
- Global PVAs filing/archiving and SharePoint maintenance.
- Global PVAs/SLAs/ICAs-related query management.
- Maintenance of Vigilance Agreements through their review cycle and update according to upcoming needs.
Management of Local PVAs
- Supporting maintenance of local PVAs through their review cycle and update according to upcoming needs.
- Local PVA filing/archiving and SharePoint maintenance.
- Local PVA-related query management.
PV Alliance & Compliance Support
- Supporting management of Local Operating Company (LOC) bi-annual reports (2 cycles/year).
- PSMF maintenance support (2 updates/year).
- Supporting Safety Agreements mailbox management.
- Email categorisation and task assignment.
Qualifications (Minimum Required)
- Focus on customers.
- Innovative and able to change.
- Pursue scientific and progress excellence.
- Work with others.
- Achieve results.
Experience (Minimum 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.
- Leadership capabilities.
- Good communication.
- 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.
- Financially intuitive.
- Knowledge of ICH guidelines.
- Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
Preferred Qualifications Include
- EudraVigilance Certification.
- 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, Medical Sciences, Life Sciences, or related area.
- *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
- **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
- ***Team leadership experience includes experience bearing overall responsibility for work products generated for customers by supporting team members operating in matrix environment, assigning, and coordinating work executed by a team of supporting staff, organizing efforts of more than one individual to achieve common team objectives.
Physical Demands/Work Environment
- Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.
- Office environment or remote.
- No special factors at this time.
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