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 an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension – Russian Language Capability to join one of our clients.

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:

• Function as nationally nominated person or back up for the local nominated person for Pharmacovigilance in respective countries assuming the PV role as defined by national law if applicable.

• Perform regulatory monitoring for impact on vigilance activities and responsibilities.

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

• Maintain oversight of proper identification of local literature articles for AE reporting as required.

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

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

• Supporting Area Safety Head in notifying local health authorities of any safety issues including SSI/ESI and Signals.

• Maintain up-to-date knowledge 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.

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

• Perform other agreed tasks assigned by manager.

• Perform document management and archiving as required.

• Perform 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.

• 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 in 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.

• Provide 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:

• Education: health care science professional e.g.: (nurse pharmacist life science degree) or equivalent training and experience.

• 1-2 years of relevant experience.

• Pharmaceutical industry experience including product vigilance responsibility role.

• Sound knowledge of general medicine pharmacy and clinical practice or another relevant scientific/medical field.

• Sound knowledge of medical terminology

• Computer literate.

• Good verbal and written communication skills.

• Ability to establish and maintain open relationships within the organization and with authorities.

• Fluency in the national language(s) and the English language. Russian Language Proficiency Preferred.

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 4000 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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