Senior Scientist, Medical Review Physician at ClinChoice

Yerevan, , Armenia -

Full Time

Start Date

Immediate

Expiry Date

04 May, 26

Salary

0.0

Posted On

03 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Interpretation, Safety Data Analysis, Signal Detection, Surveillance Strategies, Benefit-Risk Assessment, Communication Skills, Attention to Detail, Problem-Solving, Pharmacovigilance, Clinical Experience, Mentoring, Training, Collaboration, Quality Assurance, Regulatory Compliance, Data Management

Industry

Pharmaceutical Manufacturing

Description

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Scientist, Medical Review Physician on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Main Job Tasks and Responsibilities: Perform medical interpretation of safety data with client/stakeholder oversight. Identify and screen safety signals and perform validation and evaluation based on review of existing post-market data, medical/clinical literature, information from health authority databases, and other similar sources of data. Conduct a review of cases received from spontaneous and elicited consumer/patient reports in order to identify a potential or evolving safety issue. Systematically sort and analyze alerts triggered in global/client safety systems and databases and conduct a review to determine whether a pattern of clinical concern exists. Formulate surveillance strategies in order to monitor and track existing or potential safety signals. Determine and document the impact of identified safety issues on the benefit-risk and safety profile of affected client product(s). Prepare and present safety data and related information to global cross functional stakeholders, global medical organizations, and other safety governance committees. Ensure compliance to timelines, quality and trainings as specified in the SLA. Effectively organize work to complete the assigned tasks to meet deadlines Provides support during annual surveillance review and local signal detection activities. Independently handle the assigned tasks with minimal guidance & supervision and provide guidance to junior team members when required. Collaborate with subject matter experts to understand research needs and develop research questions. Mentor team members and new joiners, conduct refresher trainings and feedback sessions to team members as applicable. Secondary Responsibilities: Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum, OR no re-work. Alert and escalate to TL as required, whenever project deliverable risks are visualized OR issues encountered impacting the delivery schedule. Ensure that all assigned goals (e.g., utilization and efficiency) are met as per set standards for the performance year. Attend client, team and department meetings, complete all required trainings, and ensure completion of all relevant activities (timesheet). Contribute towards the achievement of Quality Objectives. Ensure that all project outputs and documents are always audit-ready. Awareness of global culture and drug safety, as well as global and region-specific guidelines and regulations. Ensure completion of any other tasks assigned by the reporting manager. Follow and comply with the Company’s Code of Conduct, Policies, and procedures. Comply with QMS and MD-QMS requirements. Responsible for confidentiality, integrity, availability and safeguarding of data. Responsible for reporting of security incidents and PIMS breaches as applicable. Comply with company ISMS and PIMS requirements. Demonstrate adherence and compliance to PIMS/GDPR requirements as follows: processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner. Education and Experience: Medical knowledge (MD, PharmD, Dentists; PhD in Sciences preferred). Pharmaceutical industry experience with preference in PV and specifically safety surveillance/risk management. 2 + years of work experience in Pharmacovigilance domains. Clinical experience in patient care. Strong English communication skills (verbal and written). Willingness to be flexible with working hours and accommodate colleagues in other time zones. Attention to Detail and Problem-Solving: Meticulous attention to detail and strong problem-solving abilities. Our Benefits: Flexible Working Hours Team events and end of year party Employee satisfaction survey - your feedback is important for continuous improvement Health Insurance 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. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! 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 to 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.

Responsibilities

The Senior Scientist, Medical Review Physician will perform medical interpretation of safety data and identify safety signals based on various data sources. They will also prepare and present safety data to stakeholders and ensure compliance with timelines and quality standards.