RECRUITING FOR THE ROLE OF PHARMACOVIGILANCE COMPANY DIRECTOR.
As a member of the global PV management team you will provide
leadership in setting the strategic direction of Quality and
Compliance PV activities.
This role is suited to candidates who possess strong leadership skills
and strategic thinking. Utilizing expert Good Pharmacovigilance (GVP)
and Good Clinical Practice (GCP) knowledge this role will be a trusted
business partner effectively communicating and collaborating with
senior stakeholders and leadership teams across the global
organization.
You will be a part of an expert team supporting global clinical
development and post-marketing programs.
Primary Responsibilities
? Active member of the Global R&D Quality & Compliance PV management
team
? Manage the pharmacovigilance audit program based out of the
Dublin, office This includes internal process, affiliate, distributor
and external vendor audits
? Manage and/or lead diverse & specialized types of audits or
projects involving multiple sites, commercial products and/or
therapeutic areas.
? Effective compliance reporting to senior management and relevant
quality governance forums.
? Investigate critical compliance Issues
? Support CAPA development and perform effectiveness checks of CAPAs
? Deliver end-to-end regulatory PV inspection strategy and
management, which includes facilitation of regulatory agency PV
inspections and partner audits, occurring both in-house and at
affiliates.
? Support regulatory agency inspections as needed
? Evaluate departmental and business area SOPs for fitness for
purpose and for compliance with regulatory requirements
? Provide Q&C input on new SOPs, often regarding complex processes
entailing complicated cross-functional work and inter business partner
relationships.
? Ensure adherence to departmental SOPs across sites.
? Lead intra or interdepartmental teams of an operational nature
such as preparing the Company for minor changes in regulations,
continuous improvement initiatives.
? Direct others in prioritizing their work.
Qualifications
? BA or BS and **Apply on the website**+ years of relevant
experience (**Apply on the website**+ years of relevant experience
with an MS).
? Must have significant GVP & GCP audit and compliance experience.
? Bio-pharma sponsor or CRO experience required.
? Recognized as an expert resource on a range of clinical compliance
topics.
? Strong verbal and written communication skills and interpersonal
skills.
? Proficient in Microsoft Office suite. Experience with audit
management/CAPA management programs strongly preferred.
? Excellent organization skills and project management.
? Able to work equally well as part of a team or independently
? Ability to travel approximately **Apply on the website**%
required.
FOR MORE DETAILS AND CONFIDENTIAL DISCUSSION PLEASE EMAIL OR CALL TINA
AT 1 . THORNSHAW IS A LEADING PROVIDER OF SERVICES FOR THE
PHARMACEUTICAL. LIFE SCIENCES AND MEDICAL DEVICE INDUSTRIES.
ON BEHALF OF MY CLIENT A GLOBAL PHARMACEUTICAL COMPANY, WE ARE
RECRUITING FOR THE ROLE OF PHARMACOVIGILANCE COMPANY DIRECTOR.
As a member of the global PV management team you will provide
leadership in setting the strategic direction of Quality and
Compliance PV activities.
This role is suited to candidates who possess strong leadership skills
and strategic thinking. Utilizing expert Good Pharmacovigilance (GVP)
and Good Clinical Practice (GCP) knowledge this role will be a trusted
business partner effectively communicating and collaborating with
senior stakeholders and leadership teams across the global
organization.
You will be a part of an expert team supporting global clinical
development and post-marketing programs.
Primary Responsibilities
? Active member of the Global R&D Quality & Compliance PV management
team
? Manage the pharmacovigilance audit program based out of the
Dublin, office This includes internal process, affiliate, distributor
and external vendor audits
? Manage and/or lead diverse & specialized types of audits or
projects involving multiple sites, commercial products and/or
therapeutic areas.
? Effective compliance reporting to senior management and relevant
quality governance forums.
? Investigate critical compliance Issues
? Support CAPA development and perform effectiveness checks of CAPAs
? Deliver end-to-end regulatory PV inspection strategy and
management, which includes facilitation of regulatory agency PV
inspections and partner audits, occurring both in-house and at
affiliates.
? Support regulatory agency inspections as needed
? Evaluate departmental and business area SOPs for fitness for
purpose and for compliance with regulatory requirements
? Provide Q&C input on new SOPs, often regarding complex processes
entailing complicated cross-functional work and inter business partner
relationships.
? Ensure adherence to departmental SOPs across sites.
? Lead intra or interdepartmental teams of an operational nature
such as preparing the Company for minor changes in regulations,
continuous improvement initiatives.
? Direct others in prioritizing their work.
Qualifications
? BA or BS and **Apply on the website**+ years of relevant
experience (**Apply on the website**+ years of relevant experience
with an MS).
? Must have significant GVP & GCP audit and compliance experience.
? Bio-pharma sponsor or CRO experience required.
? Recognized as an expert resource on a range of clinical compliance
topics.
? Strong verbal and written communication skills and interpersonal
skills.
? Proficient in Microsoft Office suite. Experience with audit
management/CAPA management programs strongly preferred.
? Excellent organization skills and project management.
? Able to work equally well as part of a team or independently
? Ability to travel approximately **Apply on the website**%
required.
FOR MORE DETAILS AND CONFIDENTIAL DISCUSSION PLEASE EMAIL OR CALL TINA
AT 1 . THORNSHAW IS A LEADING PROVIDER OF SERVICES FOR THE
PHARMACEUTICAL. LIFE SCIENCES AND MEDICAL DEVICE INDUSTRIES.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
