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6 days ago
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MANAGER SAFETY ANALYSIS SCIENTIST


Johnson & Johnson
Location: High Wycombe
Job type: Permanent
Sector: Medical/Pharmaceutical/Scientific
Category: Analysis Jobs
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Janssen Research & Development,
LLC, a member of the Johnson & Johnson Family of Companies, is recruiting
for a Manager Safety Analysis Scientist (SAS) located in Horsham, PA, Titusville,
NJ and High Wycombe, England or Canada.

The Manager Safety Analysis
Scientist (SAS) provides scientific expertise and leads the safety assessment
of assigned products. The Manager SAS, in partnership with the Medical Safety
Officer (MSO), is responsible for the preparation of scientific safety analysis
and evaluations, which are required for regulatory compliance and to aid in
safety-related decisions for marketed products and products in development.

The Manager SAS will:

* Support product Safety Management
Teams (SMTs) and work in close collaboration with other cross-functional safety
partners to determine a product’s safety strategy, complete safety analyses and
evaluations
* Proactively review safety data/lead
safety data review meetings and interpret safety information to make a
recommendation, supporting SMT deliverables as required
* Assist the MSO with activities
related to the SMT and with contributions to key safety and clinical documents
* Have in-depth product knowledge,
will serve as product point of contact, and will provide mentoring to, and
oversight of deliverables prepared by, other team members as needed (for
complex reports)
* Function independently, or with
moderate guidance from the Therapeutic Area Lead (TAL), be able to link
discussions to content, and deliver quality results with minimal guidance. The
Manager SAS will build alliances and be able to influence other safety partners
to shape decisions/outcomes
* Lead safety evaluations, including
strategy discussions, collaborating with Therapeutic Area Safety Head
(TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis,
report writing, and report revision
* Ensure high quality safety
evaluations and reports with minimal-to-moderate comments from stakeholders and
minimal-to-moderate revisions required
* Provide support to AD SASs for novel projects without
defined processes
* Provide input and review to key regulatory or clinical
documents as appropriate
* Demonstrate leadership in the SMT and support the MSO
* Support SMT activities (e.g. preparing and presenting
data, compiling meeting minutes, updating signal tracking information)
* Lead proactive safety data reviews, if applicable and
form a safety position across GMS which can be leveraged for aggregate
safety reports
* Provide support for Health Authority interactions
regarding safety and risk management, both written and verbal
* Contribute to cross-functional training of relevant
stakeholders
* Mentor other SASs on activities within the role
* Participate in department and/or cross-functional
initiatives and explore innovative ways of presenting data, preparing
reports, and improving efficiencies
* Assist in the creation, review and implementation of
controlled documents and other related tools
* Support audits/inspections

This position reports into the
Director, Pharmacovigilance Evaluation and Reporting, Therapeutic Area Lead

Qualifications

Qualifications:

* Bachelor’s Degree Required: Healthcare-related or
Biomedical Science and with a minimum of 9 years industry experience or
equivalent) OR
* Advanced Degree Preferred: Healthcare-related or
Biomedical Science with a minimum 6+ years industry experience or
equivalent required
* Medical writing or PV experience required
* Clinical experience preferred
* Working knowledge of medical concepts and familiarity
with safety activities in drug development and post marketing and global
safety health authority requirements
* Ability to understand and analyze complex
medical-scientific data from a broad range of sources
* Ability to interpret and present complex data to
determine benefit-risk impact
* Excellent English verbal and written communication
skills
* Ability to effectively interact with stakeholders,
including business partners
* Ability to work in a matrix environment, proven
leadership skills
* Ability to plan work to meet deadlines and effectively
handle multiple priorities
* Proficiency in Microsoft Word, Excel, and PowerPoint
* Ability to influence, negotiate and communicate with
both internal and external customers

Johnson & Johnson is an Affirmative Action
and Equal Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, age, national origin, or protected veteran
status and will not be discriminated against on the basis of disability.

Primary Location
United States-Pennsylvania-Horsham-
Other Locations
North America-Canada, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Science
Requisition ID
00001EUE
Janssen Research & Development,
LLC, a member of the Johnson & Johnson Family of Companies, is recruiting
for a Manager Safety Analysis Scientist (SAS) located in Horsham, PA, Titusville,
NJ and High Wycombe, England or Canada.

The Manager Safety Analysis
Scientist (SAS) provides scientific expertise and leads the safety assessment
of assigned products. The Manager SAS, in partnership with the Medical Safety
Officer (MSO), is responsible for the preparation of scientific safety analysis
and evaluations, which are required for regulatory compliance and to aid in
safety-related decisions for marketed products and products in development.

The Manager SAS will:

* Support product Safety Management
Teams (SMTs) and work in close collaboration with other cross-functional safety
partners to determine a product’s safety strategy, complete safety analyses and
evaluations
* Proactively review safety data/lead
safety data review meetings and interpret safety information to make a
recommendation, supporting SMT deliverables as required
* Assist the MSO with activities
related to the SMT and with contributions to key safety and clinical documents
* Have in-depth product knowledge,
will serve as product point of contact, and will provide mentoring to, and
oversight of deliverables prepared by, other team members as needed (for
complex reports)
* Function independently, or with
moderate guidance from the Therapeutic Area Lead (TAL), be able to link
discussions to content, and deliver quality results with minimal guidance. The
Manager SAS will build alliances and be able to influence other safety partners
to shape decisions/outcomes
* Lead safety evaluations, including
strategy discussions, collaborating with Therapeutic Area Safety Head
(TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis,
report writing, and report revision
* Ensure high quality safety
evaluations and reports with minimal-to-moderate comments from stakeholders and
minimal-to-moderate revisions required
* Provide support to AD SASs for novel projects without
defined processes
* Provide input and review to key regulatory or clinical
documents as appropriate
* Demonstrate leadership in the SMT and support the MSO
* Support SMT activities (e.g. preparing and presenting
data, compiling meeting minutes, updating signal tracking information)
* Lead proactive safety data reviews, if applicable and
form a safety position across GMS which can be leveraged for aggregate
safety reports
* Provide support for Health Authority interactions
regarding safety and risk management, both written and verbal
* Contribute to cross-functional training of relevant
stakeholders
* Mentor other SASs on activities within the role
* Participate in department and/or cross-functional
initiatives and explore innovative ways of presenting data, preparing
reports, and improving efficiencies
* Assist in the creation, review and implementation of
controlled documents and other related tools
* Support audits/inspections

This position reports into the
Director, Pharmacovigilance Evaluation and Reporting, Therapeutic Area Lead

Qualifications

Qualifications:

* Bachelor’s Degree Required: Healthcare-related or
Biomedical Science and with a minimum of 9 years industry experience or
equivalent) OR
* Advanced Degree Preferred: Healthcare-related or
Biomedical Science with a minimum 6+ years industry experience or
equivalent required
* Medical writing or PV experience required
* Clinical experience preferred
* Working knowledge of medical concepts and familiarity
with safety activities in drug development and post marketing and global
safety health authority requirements
* Ability to understand and analyze complex
medical-scientific data from a broad range of sources
* Ability to interpret and present complex data to
determine benefit-risk impact
* Excellent English verbal and written communication
skills
* Ability to effectively interact with stakeholders,
including business partners
* Ability to work in a matrix environment, proven
leadership skills
* Ability to plan work to meet deadlines and effectively
handle multiple priorities
* Proficiency in Microsoft Word, Excel, and PowerPoint
* Ability to influence, negotiate and communicate with
both internal and external customers

Johnson & Johnson is an Affirmative Action
and Equal Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, age, national origin, or protected veteran
status and will not be discriminated against on the basis of disability.

Primary Location
United States-Pennsylvania-Horsham-
Other Locations
North America-Canada, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Science
Requisition ID
00001EUE
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