Safety Science Director
The PositionSafety Science DirectorPortfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio.
As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.
The Portfolio Safety Scientists supports early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio.
In the post-market setting this may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.
Job
Responsibilities:
Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.
g.
, disease under study, safety profile of competitors, mechanism of action) Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance.
Contribute to the review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests Provide expert contribution to the development of the product safety strategy Take independent responsibility for risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including IB), risk communications, RMP, REMS Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication Take responsibility for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.
) Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB Responsible for coordination and collaboration with vendors servicing Safety Science Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.
g.
, IDCP, CDP) Accountable for the safety components of study reports, aggregate reports and high level regulatory documents Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures Lead the development of scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve the submissions from a safety perspective Enable/facilitate the transition of appropriate drug candidates from EMS to LMMS Demonstrates independence and high competence in the conduct of all safety science responsibilities Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams Consistently comply with all governing laws, regulations, QMS, Roche standard operating procedures (SOPs) and other guidelines Seen by peers and cross-functional colleagues as an expert in many safety science activities Willing to challenge embedded behaviors/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency.
Education, Skills and ExperienceMinimum
Qualifications:
Qualified healthcare professional or Life Sciences graduate6 or more years of drug development experience in the pharmaceutical or related industry3 years in drug safety experiencePreferred
Qualifications:
A relevant postgraduate qualification (e.
g.
PHD/MSc in a Life sciences discipline; MD, PharmD or other post-graduate health professional qualifications) would be advantageous The ability to demonstrate a broad understanding of the scientific aspects of safety, PV and clinical/patient risk management (e.
g.
via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential.
Demonstrated ability to lead and influence, with and without authority, in a global matrix environment.
Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.
Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity Demonstrated ability to effectively train others on departmental practices and processes The expected salary range for this position based on the primary location of California is $157,600 $292,600.
Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.
Benefits Relocation benefits are available for this job posting Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us.
Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date.
This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.
If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
Job SummaryJob number:
202305-111919Date posted :
2023-05-17Profession:
Data Science & AI / MLEmployment type:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.
The Portfolio Safety Scientists supports early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio.
In the post-market setting this may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.
Job
Responsibilities:
Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.
g.
, disease under study, safety profile of competitors, mechanism of action) Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance.
Contribute to the review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests Provide expert contribution to the development of the product safety strategy Take independent responsibility for risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including IB), risk communications, RMP, REMS Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication Take responsibility for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.
) Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB Responsible for coordination and collaboration with vendors servicing Safety Science Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.
g.
, IDCP, CDP) Accountable for the safety components of study reports, aggregate reports and high level regulatory documents Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.
Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures Lead the development of scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve the submissions from a safety perspective Enable/facilitate the transition of appropriate drug candidates from EMS to LMMS Demonstrates independence and high competence in the conduct of all safety science responsibilities Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams Consistently comply with all governing laws, regulations, QMS, Roche standard operating procedures (SOPs) and other guidelines Seen by peers and cross-functional colleagues as an expert in many safety science activities Willing to challenge embedded behaviors/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency.
Education, Skills and ExperienceMinimum
Qualifications:
Qualified healthcare professional or Life Sciences graduate6 or more years of drug development experience in the pharmaceutical or related industry3 years in drug safety experiencePreferred
Qualifications:
A relevant postgraduate qualification (e.
g.
PHD/MSc in a Life sciences discipline; MD, PharmD or other post-graduate health professional qualifications) would be advantageous The ability to demonstrate a broad understanding of the scientific aspects of safety, PV and clinical/patient risk management (e.
g.
via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential.
Demonstrated ability to lead and influence, with and without authority, in a global matrix environment.
Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.
Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity Demonstrated ability to effectively train others on departmental practices and processes The expected salary range for this position based on the primary location of California is $157,600 $292,600.
Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.
Benefits Relocation benefits are available for this job posting Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us.
Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date.
This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.
If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
Job SummaryJob number:
202305-111919Date posted :
2023-05-17Profession:
Data Science & AI / MLEmployment type:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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