Senior Associate, Aggregate Reporting Physician

 

 

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 Associate, Aggregate Reporting 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!

Position Overview:
The Senior Associate, Aggregate Reporting Physician position is responsible for developing, reviewing, and maintaining high-quality safety and pharmacovigilance documents that support the safety surveillance and regulatory compliance of consumer health products. It requires the ability to synthesize data from multiple sources, including individual case safety reports (ICSRs), aggregate safety data, clinical studies, epidemiological research, literature reviews, post-marketing surveillance, signal detection activities, and other safety data sources. The successful candidate will transform complex safety information into clear, concise, and scientifically accurate documents that support global pharmacovigilance activities and regulatory submissions and will work closely with Drug Safety, Medical Affairs, Regulatory Affairs, Clinical Development, Quality, and R&D teams to ensure consistent, evidence-based communication of product safety information.

Main Job Tasks and Responsibilities: 

• Prepare, review, and maintain pharmacovigilance and risk management documents for consumer health products.
• Synthesize safety information from multiple sources, including: Individual Case Safety Reports (ICSRs), Aggregate safety data analyses, Clinical trial safety data, Post-marketing surveillance data, Epidemiology studies, Published literature, Signal detection and evaluation activities, Benefit-risk assessments, Health Authority Assessment Reports.
• Draft and support the preparation of: Periodic Safety Update Reports (PSURs/PBRERs/PADERs), Ad Hoc Safety Reports, Development Safety Update Reports (DSURs), Signal assessment reports, Aggregate safety reports, Risk management documentation, Health authority responses, Safety narratives, Safety sections of regulatory submissions, Safety surveillance reports and presentations, Analysis and evaluation for the Safety Management Teams (SMT).
• Collaborate with Safety Scientists, Medical Reviewers and others to evaluate emerging safety information and communicate findings effectively.
• Assist in the interpretation of safety trends, potential signals, and benefit-risk considerations.
• Support literature surveillance activities and summarize relevant safety findings.
• Contribute to the development of safety conclusions and evidence-based recommendations.
• Support the preparation, review, and analysis of risk management activities and reports.
• Ensure all documents comply with global pharmacovigilance regulations, company SOPs, and applicable guidance documents.
• Maintain high standards of scientific accuracy, consistency, grammar, and document quality.
• Perform quality control reviews of safety documents and ensure timely delivery of assigned projects.
• Support inspection and audit readiness activities through accurate documentation practices.

Education and Experience:

• Advanced degree required: PharmD, PhD, MD, MPH, MS, or equivalent scientific discipline.
• 3–6 years of experience in pharmacovigilance, drug safety, medical writing, regulatory writing, or related pharmaceutical, consumer health, or medical device industries.
• Experience preparing safety and pharmacovigilance documents preferred.
• Familiarity with global pharmacovigilance regulations and safety reporting requirements.
• Experience working in a matrixed environment with multiple stakeholders.
• Strong understanding of: Clinical research methodologies, Epidemiology and biostatistics, Evidence-based medicine, Regulatory and scientific communication requirements, Safety and benefit-risk assessment principles
• Expertise in literature evaluation and scientific data interpretation.
• Ability to critically analyze multiple complex scientific information and identify key insights to drive product safety.
• Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) with strong document formatting, data analysis, and presentation capabilities.
• Excellent medical writing, editing, and proofreading skills.
• Exceptional grammar, attention to detail, and document quality standards.
• Strong analytical and critical thinking capabilities.
• Effective project management and organizational skills
• Exceptional Communication and Presentation Skills, with the ability to convey complex clinical and scientific information clearly and effectively to diverse audiences.
• Ability to work independently while managing multiple priorities and deadlines.

Our Benefits: 

• Flexible Working Hours
• Full performance and development process with end of year reviews
• 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.