Regional Safety Lead 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 Regional Safety Lead Consultant 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:
The Regional Safety Lead is a local pharmacovigilance position under the local Pharmacovigilance Team, part of the Medical Safety Organization who is responsible for maintaining oversight and conduct local pharmacovigilance activities. The local pharmacovigilance organization conducts their activities in close collaboration with other local departments as well as with the global pharmacovigilance organization.:
Key Responsibilities
Performs EMEA-wide local Regulatory Intelligence for the product portfolio and supports the maintenance of up-to-date knowledge of local requirements for pharmacovigilance, including reporting requirements (for all applicable product classes in the territory) and collaborating with the Area Safety Head to implement process changes required for the identification of new requirements
Compiling local Pharmacovigilance Sub- System Files (PSSF) globally with a close collaboration with the relevant Area Safety Heads and Area Safety Leads for the respective regions to obtain relevant information for the final documents.
Global and regional project participation as applicable
Support of individual Area Safety Heads and coverage of mailbox and oversight activities in specific clusters during absence of the Area Safety Head/Lead
Education and Experience:
✓ 6-8 years of Pharmacovigilance experience
✓ Experience in compiling of pharmacovigilance relevant documents (PSMF or PSSF compilation experience)
✓ Fluency in the English & Turkish languages
✓ Pharmaceutical industry experience including product vigilance responsibility role
✓ Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field
✓ Proven ability to organize workflow activities and manage multiple critical issues
✓ Awareness 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
✓ Proven 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
✓ Education: health care science professional (preferably Physician or Pharmacist).
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.
#LI-PB1 #LI-Remote
Key words: PSMF, PSSF,PV, Pharmacovigilance , Regional Lead
Regional Safety Lead 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 Regional Safety Lead Consultant 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:
The Regional Safety Lead is a local pharmacovigilance position under the local Pharmacovigilance Team, part of the Medical Safety Organization who is responsible for maintaining oversight and conduct local pharmacovigilance activities. The local pharmacovigilance organization conducts their activities in close collaboration with other local departments as well as with the global pharmacovigilance organization.:
Key Responsibilities
Performs EMEA-wide local Regulatory Intelligence for the product portfolio and supports the maintenance of up-to-date knowledge of local requirements for pharmacovigilance, including reporting requirements (for all applicable product classes in the territory) and collaborating with the Area Safety Head to implement process changes required for the identification of new requirements
Compiling local Pharmacovigilance Sub- System Files (PSSF) globally with a close collaboration with the relevant Area Safety Heads and Area Safety Leads for the respective regions to obtain relevant information for the final documents.
Global and regional project participation as applicable
Support of individual Area Safety Heads and coverage of mailbox and oversight activities in specific clusters during absence of the Area Safety Head/Lead
Education and Experience:
✓ 6-8 years of Pharmacovigilance experience
✓ Experience in compiling of pharmacovigilance relevant documents (PSMF or PSSF compilation experience)
✓ Fluency in the English & Turkish languages
✓ Pharmaceutical industry experience including product vigilance responsibility role
✓ Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field
✓ Proven ability to organize workflow activities and manage multiple critical issues
✓ Awareness 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
✓ Proven 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
✓ Education: health care science professional (preferably Physician or Pharmacist).
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.
#LI-PB1 #LI-Remote
Key words: PSMF, PSSF,PV, Pharmacovigilance , Regional Lead