Synapmed, a leading Contract Research Organization (CRO), is seeking a highly motivated Safety Physician: PV with expertise in ICSR, Aggregate Reporting, and Signal Detection. If you’re passionate about leveraging your medical background in a cutting-edge environment, this opportunity is perfect for you.
Company Introduction
Synapmed (formerly AstaLynx Global) specializes in providing Real-World Data and AI-enabled solutions across the Target to Market spectrum. Synapmed is at the forefront of innovative and compliant product safety services in emerging areas like gene therapy, immunotherapy, RNA-based therapy, digital therapy, microbiome-based therapy, and aging-related therapy. They also serve established firms in pharmaceuticals, medical devices, biotech, nutraceuticals, and cosmetics. Synapmed integrates advanced technologies to streamline processes, enhance efficiencies, and ensure robust safety offerings.
Responsibilities in Job
1. ICSR Experience
- Manage Individual Case Safety Reports (ICSR) in adherence to regulatory requirements.
2. Aggregate Report Experience
- Compile, analyze, and summarize data for aggregate reports.
- Prepare Periodic Safety Update Reports (PSURs) and other regulatory documents.
3. Signal Detection
- Perform signal detection activities using clinical trial and post-marketing data.
- Collaborate with safety teams to assess and prioritize identified signals for further evaluation.
4. Study Document Review
- Review study documents, including Clinical Study Reports (CSR), Study Management Plans (SMP), protocols, and Informed Consent Forms (ICF).
- Ensure compliance with regulatory and company standards.
Qualifications
- Education: MBBS and MD degree from a recognized institution.
- Experience: Proven track record in pharmacovigilance, particularly in aggregate reporting and signal detection.
- Availability: Immediate availability to join the team.
- Strong understanding of regulatory guidelines and pharmacovigilance practices.
Skills
Mandatory Skills
- Expertise in safety databases and analytical tools.
- Excellent written and verbal communication skills.
- Attention to detail and strong analytical abilities.
Preferred Skills
- Familiarity with Good Clinical Practice (GCP).
- Ability to manage multiple priorities while working collaboratively within a team.
How to Apply
Interested candidates can apply by submitting their resume and cover letter detailing relevant experience to gaurav.mishra@synapmedglobal.com.
