We are looking for a "Safety Specialist" for our global business partner operating in the biopharmaceutical industry.
Knowledge of local pharmacovigilance regulations,
Utilize and proactively participate in the Affiliate Patient Safety Network and access available Patient,
...
safety specialist.
- kadıköy, istanbul (europe)
- posted 2 days ago
- closes 31 march 2025
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job details
Safety resources such as the Agreement Repository, Patient Safety Shared drive and the Patient Safety SharePoint to ensure access to current information, including global PV Agreements, PBRERs/PSURs, RMPs and the Pharmacovigilance System Master File,
Fulfil the local legal PV responsible role,
Support the communication of safety related issues and information that may be of relevance to the identification of potential safety signals to global Patient Safety local stakeholders the safety profile of locally marketed products and any emerging safety concerns local studies and solicited programmes ongoing in the region and local post approval commitments,
Local licensing agreements, (if applicable)
Ensure close partnership with local stakeholders via, awareness and input into new product approvals and oversight of local solicited programs, providing support and review of contracts to ensure alignment with global standards,
Ensure availability of current organisation charts, job descriptions, Curriculum Vitae and training records for safety personnel at the national level,
Train applicable staff and vendors in the Turkiye cluster on safety reporting procedures including the timely reporting of safety information, new hire training, sales and solicited programs training and ensuring all training is documented,
Maintain knowledge of global Procedural Documents as they pertain to the national level and ensure that local Procedural Documents, including a local Business Continuity Plan / Crisis Management Plan are in place for specific local processes that are not covered by a global Procedural Document,
Ensure an after-hours process is in place locally for the receipt of safety requests and that the system is tested at least annually and that the test is documented,
Review the monthly global compliance reports produced by Patient Safety and take necessary corrective actions locally as applicable,
Ensure oversight of local Individual Case Safety Reports, (ICSRs)
Ensure archiving of safety data in accordance with the company's policy and national requirements,
Support internal PV audits, as required.
show moreFulfil the local legal PV responsible role,
Support the communication of safety related issues and information that may be of relevance to the identification of potential safety signals to global Patient Safety local stakeholders the safety profile of locally marketed products and any emerging safety concerns local studies and solicited programmes ongoing in the region and local post approval commitments,
Local licensing agreements, (if applicable)
Ensure close partnership with local stakeholders via, awareness and input into new product approvals and oversight of local solicited programs, providing support and review of contracts to ensure alignment with global standards,
Ensure availability of current organisation charts, job descriptions, Curriculum Vitae and training records for safety personnel at the national level,
Train applicable staff and vendors in the Turkiye cluster on safety reporting procedures including the timely reporting of safety information, new hire training, sales and solicited programs training and ensuring all training is documented,
Maintain knowledge of global Procedural Documents as they pertain to the national level and ensure that local Procedural Documents, including a local Business Continuity Plan / Crisis Management Plan are in place for specific local processes that are not covered by a global Procedural Document,
Ensure an after-hours process is in place locally for the receipt of safety requests and that the system is tested at least annually and that the test is documented,
Review the monthly global compliance reports produced by Patient Safety and take necessary corrective actions locally as applicable,
Ensure oversight of local Individual Case Safety Reports, (ICSRs)
Ensure archiving of safety data in accordance with the company's policy and national requirements,
Support internal PV audits, as required.
We are looking for a "Safety Specialist" for our global business partner operating in the biopharmaceutical industry.
Knowledge of local pharmacovigilance regulations,
Utilize and proactively participate in the Affiliate Patient Safety Network and access available Patient,
Safety resources such as the Agreement Repository, Patient Safety Shared drive and the Patient Safety SharePoint to ensure access to current information, including global PV Agreements, PBRERs/PSURs, RMPs and the Pharmacovigilance System Master File,
Fulfil the local legal PV responsible role,
Support the communication of safety related issues and information that may be of relevance to the identification of potential safety signals to global Patient Safety local stakeholders the safety profile of locally marketed products and any emerging safety concerns local studies and solicited programmes ongoing in the region and local post approval commitments,
Local licensing agreements, (if applicable)
Ensure close partnership with local stakeholders via, awareness and input into new product approvals and oversight of local solicited programs, providing support and review of contracts to ensure alignment with global standards, ...
Knowledge of local pharmacovigilance regulations,
Utilize and proactively participate in the Affiliate Patient Safety Network and access available Patient,
Safety resources such as the Agreement Repository, Patient Safety Shared drive and the Patient Safety SharePoint to ensure access to current information, including global PV Agreements, PBRERs/PSURs, RMPs and the Pharmacovigilance System Master File,
Fulfil the local legal PV responsible role,
Support the communication of safety related issues and information that may be of relevance to the identification of potential safety signals to global Patient Safety local stakeholders the safety profile of locally marketed products and any emerging safety concerns local studies and solicited programmes ongoing in the region and local post approval commitments,
Local licensing agreements, (if applicable)
Ensure close partnership with local stakeholders via, awareness and input into new product approvals and oversight of local solicited programs, providing support and review of contracts to ensure alignment with global standards, ...
Ensure availability of current organisation charts, job descriptions, Curriculum Vitae and training records for safety personnel at the national level,
Train applicable staff and vendors in the Turkiye cluster on safety reporting procedures including the timely reporting of safety information, new hire training, sales and solicited programs training and ensuring all training is documented,
Maintain knowledge of global Procedural Documents as they pertain to the national level and ensure that local Procedural Documents, including a local Business Continuity Plan / Crisis Management Plan are in place for specific local processes that are not covered by a global Procedural Document,
Ensure an after-hours process is in place locally for the receipt of safety requests and that the system is tested at least annually and that the test is documented,
Review the monthly global compliance reports produced by Patient Safety and take necessary corrective actions locally as applicable,
Ensure oversight of local Individual Case Safety Reports, (ICSRs)
Ensure archiving of safety data in accordance with the company's policy and national requirements,
Support internal PV audits, as required.
show moreTrain applicable staff and vendors in the Turkiye cluster on safety reporting procedures including the timely reporting of safety information, new hire training, sales and solicited programs training and ensuring all training is documented,
Maintain knowledge of global Procedural Documents as they pertain to the national level and ensure that local Procedural Documents, including a local Business Continuity Plan / Crisis Management Plan are in place for specific local processes that are not covered by a global Procedural Document,
Ensure an after-hours process is in place locally for the receipt of safety requests and that the system is tested at least annually and that the test is documented,
Review the monthly global compliance reports produced by Patient Safety and take necessary corrective actions locally as applicable,
Ensure oversight of local Individual Case Safety Reports, (ICSRs)
Ensure archiving of safety data in accordance with the company's policy and national requirements,
Support internal PV audits, as required.
qualifications
Scientific background along with a medical-scientific university degree e.g., Medicine or Pharmacy,
Some experience in pharmacovigilance, (however will consider appropriate applicants with little to no experience if they have a relevant degree and are able to demonstrate an understanding in the science of pharmacovigilance)
Effective communicator (written and oral); concise, accurate and business appropriate,
Proven ability to work cross-functionally,
Demonstrates teamwork and initiative,
Excellent attention to detail and be able to demonstrate and deliver high-quality work.
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