Manager, Safety and Compliance Consultant

re 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 Manager, Safety and Compliance Consultant for 12 months Contract with possibility of extension 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.
Responsibilities
Position Summary
Responsibility for pharmacovigilance oversight, ensuring compliant management of internal and external organizations that are required to report adverse events and product quality complaints to ensure that Client supported products are safe and effective for human use. Manages effective relations with Client internal and external partners to drive regulatory, legal and corporate compliance regarding multiple aspects and components of a quality safety reporting system (e.g., appropriate contract language, vendor training, reporting reconciliation and program management). Additionally, is responsible for maintenance of training materials for external partner training. Provides quality support to ensure compliance with policies and SOPs related to adverse event (AE) and product quality complaint (PQC) reporting for the Client
Key Responsibilities
Ensures compliant program management for safety reporting in accordance with US and international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines. Develops and ensures that compliance metrics demonstrate oversight. Implements additional oversight measures to monitor compliance.
Develops programs and processes to ensure proactive oversight of Client external partner programs to ensure that processes are in place for both AE and PQC reporting
Monitors timely submission of Client sponsored clinical activities managed by external partners individual case safety reports to the Client drug safety units and takes appropriate action for non-compliance; initiates effective solutions for potential gaps
Performs trend analysis; identifies problems and opportunities for continuous improvement of external partner safety reporting processes. Leverages existing and new technology to assist in solution development
Initiates deviation memos, event descriptions, and corrective action plans in an effective and timely manner, appropriately maintains all documentation, and follows plan through completion.
Drives corrective and preventative actions to address audit and inspection findings related to external partner safety reporting and ensures that responses are executed compliantly
Oversight includes the assessment of a potential safety compliance risks associated with clinical activities sponsored by the Client. Develops programs to prevent non-compliant issues from arising
Effectively partners with Client Operation Companies such as, Medical Affairs, Market Research, Real World Evidence, Strategic Customer Group teams to ensure that all clinical activities are compliant with the relevant safety reporting procedures, guidelines and processes.
Manages risk associated with vendors conducting clinical activities on behalf of the Client receiving adverse events by using innovation to improve areas of deficiencies.
Ensures Client procedural control documents are in conformance with relevant Client procedural documents including policies, standard operating procedures, guidance documents and work instructions.
Manages multiple projects simultaneously (works with external service providers and third-party safety agreement partners).
Maintains safety compliance training materials for all Client staff, internal and external associates and vendors including contractors responsible for collecting and handling safety information.
Designs and delivers training programs associated with pharmacovigilance and safety activity.
Supports Client and other Client business partners in pharmacovigilance activities as appropriate.
Minimum Qualifications
Education/Experience:
Bachelor’s degree / MA/MS/MBA (Medical /Pharmacy/Life Sciences/Nursing)
· Prior experience in a safety compliance role required (i.e. - prior experience with regulatory mandated processes for handling adverse events and product quality complaints. Experience interfacing with auditing and compliance organization)
· Knowledge of the drug safety regulations and reporting process.
· Understanding of medical/pharmacology/nursing terminology
· Knowledge of Good Clinical Practices (GCP) related to clinical safety documentation and reports
· Excellent communication skills and influencing skills required to interface with multiple parties in development and implementation processes.
· Strong knowledge of U.S. adverse event reporting regulations
· Excellent planning, organizational and interpersonal skills.
· Familiarity with Customer Response Management systems, preferred.
· Strategic Thinking
· Big Picture Orientation w/Attention to Detail
· Collaboration and Teaming
· Sense of Urgency
· Self Awareness/Adaptability
· Results / Performance Driven
Knowledge, Skills and Abilities:
Strong cross‑functional collaboration and stakeholder management skills
Ability to influence within function, cross‑functionally, and globally
Excellent organizational, analytical, and problem‑solving abilities
High attention to detail with strong documentation practices
Ability to manage multiple priorities in a regulated environment
· Proficiency with data reconciliation, and electronic document regulatory information management systems
Additional Requirements
· Rare travel required
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 ave