Specific Job Description
Key Accountabilities
1. Product Safety Surveillance
- Handling of all local safety information, including collection, registration, translation from local language into English, and transmission to GDS as applicable in a timely manner
- Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner
- Performing screening of relevant local medical/scientific literature in accordance with GDS procedures and local requirements (where applicable)
- Performing screening of relevant local health authority web sites according to global standards as defined by relevant quality documents (where applicable)
- Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed
- Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling
- Performing required safety activities in the absence of the SSC Manager
- Timely submission of expedited ICSRs to concerned local health authorities (where applicable)
- Support of e-reporting in e-reporting ready countries (where applicable)
- Timely submission of expedited cases to concerned local/central EC/IRBs as applicable
- Timely submission of safety issue reports to concerned local health authorities
- Timely submission of safety issue reports to concerned local/central EC/IRBs as applicable
- Using applicable tools (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines
- Supporting the SSC Manager to ensure compliance reports to GDS via the applicable technical tool (e.g. SCCT) in a timely manner
- Contributions to the Local PV file in close collaboration with Local PV Responsible (LPVR) persons to support completeness, accuracy and that relevant information is updated in a timely manner
- Supporting the SSC Manager that a complete overview on relevant local / global clinical studies and PDCS (ongoing and planned) in the local affiliates is kept
- Supporting the SSC Manager that current global procedures for the handling of PDCS and clinical studies are followed
- Completion of all mandatory PV trainings in a timely manner
- Supporting PV training activities under the supervision of the SSC Manager
- Supporting the SSC Manger in PV related trainings as required
Strategic Impact
N/A
Scope of People Responsibility
N/A
Cooperation
Internally
Externally
- GDS Regions
- GDS Operations
- GDS Medicine
- GDS Compliance
- Medial Affairs
- Commercial
- Regulatory Affairs
- Government Affairs
- Quality Assurance within the countries and with the region.
- Health Authorities
- Ethics Committees as applicable
Candidate’s Profile
Education
- Medical, Pharmaceutical, health care background or relevant working experience
- Fluent in written and spoken local language and English
Work Experience
·Experience in the pharmaceutical industry or health authority
- Good knowledge of local regulatory pharmacovigilance legislation
- Good understanding of drug development and life-cycle management
Job specific Competencies Skills
·Strong intercultural skills (developed from practical experience)
- Strong team-working skills – working across cultural and functional boundaries, and participating ‘virtual teams’.
- Good problem-solving and decision-making ability.
- Good organisational skills, ability to prioritise work and adapt rapidly to changing priorities.
- Ability to manage multiple situations / issues under time pressure.
- Effective presentation and training skills.