Safety Physician, Bulgaria, Serbia (client-dedicated) - 12 months

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

 

The position is currently on 12 months` fixed term contract with the opportunity to be prolonged.

Discover Impactful Work:

The Safety Phisycian provides medical and operational oversight for end-to-end medical review activities supporting global pharmacovigilance, including individual case safety report (ICSR) medical assessment, submission readiness for high-interest cases, and coding standards oversight. This role helps develop, revise and maintain the  ICSR Medical Review process and ensures consistent, timely, and inspection-ready execution aligned with global pharmacovigilance regulations and internal quality standards. 

This is a highly collaborative, outward-facing role focused on PV quality, ensuring clinically meaningful data collection, and support compliant, inspection-ready pharmacovigilance activities.  Partners closely with Benefit Risk and Medical Safety teams, and external vendors/partners working cross-functionally, the role acts as a primary point of contact (PoC) for medical review requirements.  Provides subject matter expertise (SME) input to conventions/training, and drives proactive operational leadership, performance monitoring, and continuous improvement for the medical review operating model aligned with departmental and company goals.

A day in the Life:

• Provide medical review and assessment for ICSRs as required, including targeted focus on high interest/priority cases to ensure submission readiness (e.g., completeness, medical coherence, and regulatory compliance).
• Lead assigned supplemental medical review of key cases as needed, ensuring appropriate clinical interpretation, seriousness/expectedness considerations, and consistent medical documentation in the safety database.
• Provide targeted off-line quality control (QC) for medical review and/or case processing, including identification of recurrent issues, root cause analysis, and improvement actions.
• Lead targeted follow-up strategies and engage directly with medical affairs, healthcare professionals and vendors for priority or complex cases to ensure clinically relevant, complete, and submission-ready safety information is obtained in a timely manner.
• Oversee ICSR coding standards, ensuring consistent application of coding conventions (e.g., MedDRA and WHO Drug as applicable) and alignment with global standards and internal guidance.
• Perform and/or coordinate coding standards review activities, including trending findings, training needs identification, and updates to conventions and guidance.
• Contribute to the development, maintenance, and delivery of PV standards, conventions, and training materials related to asset insights, medical review and coding quality.
• Provide medical expertise and support to Benefit-Risk activities and safety strategy as delegated, including collaboration with asset/candidate Benefit-Risk leads and safety physicians/scientists as applicable.
• Support Literature QC activities as required (e.g., QC support to literature screening outputs impacting medical review/case processing), ensuring quality, compliance, and traceability.
• Act as an SME during internal audits, vendor audits, and regulatory inspections, support readiness activities including evidence preparation and response development.
• Provide proactive operational management and oversight of the medical review model, including, prioritization, monitoring of adherence to timelines, and escalation of risks/issues.
• Act as point of contact (PoC) for medical review requirements across GPV Reporting Operations, Patient Benefit Risk and Medical Safety, PV Quality, and relevant cross-functional stakeholders.
• Support the development of, revision and maintenance of the medical review process, ensuring a clearly defined, documented, and scalable medical review process across clinical trial and post-marketing case processing.
• Contribute to governance with external vendors/partners for medical review activities, including performance oversight and corrective/preventive actions (CAPA) where needed
• Partner with PV Operations leadership to ensure alignment and execution of medical review activities with broader PV operational strategy, including support for multi-year roadmaps and transformation automation initiatives.
• Monitor operational and quality metrics for medical review (e.g., timeliness, right-first-time quality, and submission readiness indicators) and drive improvements.  

Education:

• Ph.D. or Medical Degree (M.D.)

Knowledge, Skills, Abilities:

• Experience in the pharmaceutical industry or a clinically oriented discipline, including extensive knowledge in the conduct of ICSR management, reporting requirements, literature surveillance monitoring, safety data management systems and the compilation and/or analysis of aggregate safety data. 
• Minimum 2 - 3 years of experience in pharmacovigilance / drug safety with demonstrated medical review of ICSRs and understanding of PV regulations in both clinical and post-marketing settings. 
• Working knowledge of MedDRA and WHO Drug coding principles and their application to ICSR quality and reporting.
• Experience in operational oversight and/or leading cross-functional processes, including vendor oversight and performance monitoring, desired.
• Strong communication skills, and the ability to convey complex technical information to diverse audiences and various levels of the organization. 
• Self-motivated with a proactive, problem-solving mindset and ability to drive continuous improvements and develop a diverse global PV team. 
• Ability to lead, drive and execute complex projects independently  
• Strong analytical and risk assessment skills, with the ability to anticipate challenges and implement effective solutions. 

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.