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7 months ago
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Manager, Pharmacovigilance Strategic Lead


Johnson & Johnson
Location: UK
Job type: Permanent
Category: Marketing Manager
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Johnson & Johnson Consumer Inc, a member of
Johnson & Johnson's Family of Companies, is recruiting for a Manager,
Pharmacovigilance Strategic Lead to be based in one of the following
locations: Fort Washington, PA; Skillman, NJ; or Maidenhead, UK.

Johnson
& Johnson Family of Companies touches more than a billion people’s lives
each day through our health care products and services, our corporate giving,
and the volunteer efforts of our employees. The Johnson & Johnson Group of
Consumer Companies develop and market beloved brands that address the needs of
consumers and health care professionals worldwide. Our portfolio ranges across
several distinct business units: Baby Care, Oral Care, Compromised Skin
Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.

* The BioResearch Quality and Compliance (BRQC)
Pharmacovigilance (PV) Lead is responsible for management and oversight of the
Pharmacovigilance and Cosmetovigilance audit programs for JJFCC.

* Design and implement the risk-based audit and
quality assurance oversight strategy covering GVP regulated activities for
internal processes/regulated systems, service providers, affiliates and
licensing partners.

* Monitor the GVP processes and activities through
periodic risk assessment and risk-based routine audits.

* Provide actionable data to senior management
based on analysis of data (audit/inspection/risk) and identification of
trends.

* Contribute to the preparation for and management
of regulatory authority inspections in accordance with the Inspection
management strategy.

* Train and mentor BRQC Consumer auditors and
review all Consumer PV audit reports to ensure consistent and compliant audit
conduct and reporting.

Qualifications

* A minimum of a Bachelor’s Degree (or equivalent
degree) is required.
* A minimum of 7 years of professional experience
in a highly regulated industry (i.e. pharmaceutical, OTC, cosmetics) is
required.
* A minimum of 5 years of experience in GVP
related discipline is required.
* Demonstrated applied knowledge of drug
development processes, pharmacovigilance regulatory requirements required.
* Project management skills required.
* Ability to assimilate new and emerging
compliance information or trends is required.
* Experience, competency, and proven track record
developing audit and quality oversight strategies in GVP areas is required.
* Experience supporting regulatory authority
inspections is preferred.
* Proficiency in the conduct of GVP related audits
is desirable.

This position will be based in one of the following
locations: Fort Washington, PA;
Skillman, NJ; or Maidenhead, UK and will require approximately 20-25%
domestic/international travel.

Johnson &
Johnson Family of Companies are equal opportunity employers, and all qualified
applicants will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, genetic information,
national origin, protected veteran status, disability status, or any other characteristic
protected by law.

BE VITAL in your career, Be seen for the talent you bring to your work.
Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location
United States-New Jersey-Skillman
Other Locations
North America-United States-Pennsylvania-Fort Washington, Europe/Middle East/Africa-United Kingdom-England-Maidenhead
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Assurance
Requisition ID
00001C23
Johnson & Johnson Consumer Inc, a member of
Johnson & Johnson's Family of Companies, is recruiting for a Manager,
Pharmacovigilance Strategic Lead to be based in one of the following
locations: Fort Washington, PA; Skillman, NJ; or Maidenhead, UK.

Johnson
& Johnson Family of Companies touches more than a billion people’s lives
each day through our health care products and services, our corporate giving,
and the volunteer efforts of our employees. The Johnson & Johnson Group of
Consumer Companies develop and market beloved brands that address the needs of
consumers and health care professionals worldwide. Our portfolio ranges across
several distinct business units: Baby Care, Oral Care, Compromised Skin
Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.

* The BioResearch Quality and Compliance (BRQC)
Pharmacovigilance (PV) Lead is responsible for management and oversight of the
Pharmacovigilance and Cosmetovigilance audit programs for JJFCC.

* Design and implement the risk-based audit and
quality assurance oversight strategy covering GVP regulated activities for
internal processes/regulated systems, service providers, affiliates and
licensing partners.

* Monitor the GVP processes and activities through
periodic risk assessment and risk-based routine audits.

* Provide actionable data to senior management
based on analysis of data (audit/inspection/risk) and identification of
trends.

* Contribute to the preparation for and management
of regulatory authority inspections in accordance with the Inspection
management strategy.

* Train and mentor BRQC Consumer auditors and
review all Consumer PV audit reports to ensure consistent and compliant audit
conduct and reporting.

Qualifications

* A minimum of a Bachelor’s Degree (or equivalent
degree) is required.
* A minimum of 7 years of professional experience
in a highly regulated industry (i.e. pharmaceutical, OTC, cosmetics) is
required.
* A minimum of 5 years of experience in GVP
related discipline is required.
* Demonstrated applied knowledge of drug
development processes, pharmacovigilance regulatory requirements required.
* Project management skills required.
* Ability to assimilate new and emerging
compliance information or trends is required.
* Experience, competency, and proven track record
developing audit and quality oversight strategies in GVP areas is required.
* Experience supporting regulatory authority
inspections is preferred.
* Proficiency in the conduct of GVP related audits
is desirable.

This position will be based in one of the following
locations: Fort Washington, PA;
Skillman, NJ; or Maidenhead, UK and will require approximately 20-25%
domestic/international travel.

Johnson &
Johnson Family of Companies are equal opportunity employers, and all qualified
applicants will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, genetic information,
national origin, protected veteran status, disability status, or any other characteristic
protected by law.

BE VITAL in your career, Be seen for the talent you bring to your work.
Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location
United States-New Jersey-Skillman
Other Locations
North America-United States-Pennsylvania-Fort Washington, Europe/Middle East/Africa-United Kingdom-England-Maidenhead
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Assurance
Requisition ID
00001C23

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