Senior Area/Local Safety Officer 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 a Senior Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients.

The Senior Area Safety Officer 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 assigned territories main point of contact for pharmacovigilance matters (including Cosmetovigilance, materiovigilance and nutrivigilance) with the local health authority.

They will ensure that appropriate product vigilance and risk management systems are set in place to assure 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:

 

Oversight of the PV System & Overall responsibilities

Provide oversight of vendor resources within AMET

Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files.

Perform other agreed tasks assigned by manager.

Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).

Safety Management & Reporting

Receive and support the Area Safety Head in the responses to safety-related health authority queries.

Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).

Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required. 

Perform document management and archiving as required.

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

Perform regulatory monitoring for impact on vigilance activities and responsibilities.

Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.

Manage reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other departments as applicable.

Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance, 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.

Ensure pharmacovigilance compliance of local company sponsored programs and research activities as applicable.

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

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

Develop, update, and implement local procedures to ensure compliance with global procedures and national requirements.

Ensure current knowledge of all relevant company procedures and training.

Support 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 plans as applicable.

Management of PV clauses to be included within local agreements.

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

 

Education and Experience:

 

Health care science professional e.g.: (Physician, Pharmacist)

At minimum 3 years’ experience.

Pharmaceutical industry experiences including product vigilance responsibility role. Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field. Proven ability to organize workflow activities.  Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology. Knowledge of global, regional, and local procedural documents as applicable. Computer literate with knowledge of relevant IT safety systems. Good verbal and written communication skills. 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 English language.

Knowledge of Arabic, Turkish languages would be an advantage

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: Area Safety Officer, Local Safety Officer, PV, QC, CAPA

 

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