Area Safety Head Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

 

ClinChoice is searching for Area Safety Head Consultant (Local PV UK, Ireland, Nordics) for 12 months Contract with possibility of extension to join one of our clients.

Hybrid – 2 to 3 days a week

Location - 50-100 Holmers Farm Way, High Wycombe UK

The Area Safety Head is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

This role will act as the Local Operating Company (LOC)’s and assign territories (as applicable) main point of contact for pharmacovigilance matters with the local health authority.

They will ensure that appropriate product vigilance and risk management systems are set in place to ensure appropriate oversight of products within its responsibility.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment

with the client’s counterparts.  

 

 

Main Job Tasks and Responsibilities:

 

Act as Local Nominated Person:

 

Function as nationally nominated person for Pharmacovigilance in respective countries assuming the PV role as defined by national law. Collaborate with the QPPV offices as required.

 

Oversight of the PV System & Overall responsibilities :

Provide line management and/or oversight of vendor resources in the countries in scope.

Function as a delegate for the Regional Safety Head, when required.

Managing and coaching the direct reports as applicable.

Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level.

Escalate compliance issues in a timely manner to Regional Safety Head to ensure appropriate mitigation is implemented.

Advise the local business on the PV impact of local organized data collection programs.

Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.

Identify periods of high PV workload and manage PV resource appropriately to address them.

Providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files while collaborating with the global team to meet requirements for local PSMFs if applicable.

Safety Management & Reporting:

Maintaining oversight of local requirements for pharmacovigilance, cosmetic and device vigilances, including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.

Maintain oversight on day-to-day AE inbound and outbound reporting as applicable.

Supporting in the responses to safety-related health authority queries in the territory if applicable.

Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups of any changes to local laws and regulations regarding safety.

Accountable for the provision of information to the global teams for local activities compliance with individual cases and periodic safety reporting, implementing of risk management plans, and key performance indicators related to overseeing local implementation of any other specific risk management activities.

Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.

Perform translation for ICSR and PV-related documents, as required.

Collaboration & Support

Provide technical and strategic input and participate in projects/ workstreams led by the KMS teams or LOC.

Procedural Document:

Ensure implementation of the local procedures where applicable and assess the impact of changes to the global procedure to local procedures.

     Audit & inspection readiness:

Lead local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.

     PV contract management

     Maintain an oversight into the local PVAs and ensure local implementation, including LSU                  training and adherence to PVAs.

Business Continuity

Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage)

 

Education and Experience:

 

 

Health care science professional (preferably Physician or Pharmacist)

 

At minimum 6-8 years of relevant experience.

Pharmaceutical industry experiences include product vigilance responsibility role. Experience as line manager and vendor resource oversight. Ability to organize workflow activities and manage multiple critical issues. Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology. Expert knowledge of global, regional, and local procedural documents as applicable. Computer literate with knowledge of relevant IT safety systems. Excellent verbal and written communication skills. Ability to negotiate and communicate with internal and external customers. Ability to establish and maintain open relationships within the organization and with authorities. Demonstrable knowledge of all local requirements and of global aspects of product safety.

Fluency in the national language(s) and the English language.

MHRA inspection experience (front room, being interviewed)

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

 

Who will you be working for?

 

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

 

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

 

Key words: LSO, SAFETY, Pharmacovigilance, MHRA

 

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