If you are seeking an exciting opportunity to contribute to the future of patient safety in the pharmaceutical industry, look no further! Synapmed, a leading Contract Research Organization (CRO), is on the lookout for a Safety Scientist to join our innovative team in Bengaluru, Karnataka, India. This remote, full-time position offers the chance to work at the forefront of pharmacovigilance, signal management, and aggregate reporting in clinical trials—a critical role for anyone passionate about ensuring drug safety.
Why Choose Synapmed?
Synapmed, formerly known as AstaLynx Global, is recognized for its commitment to providing cutting-edge solutions in life sciences, including emerging therapies like gene therapy, immunotherapy, and RNA-based therapy. Our mission is to leverage technology and data to streamline processes and enhance product safety services for our clients, which span various sectors, including pharmaceuticals, biotechnologies, and nutraceuticals.
As a part of our team, you’ll have the opportunity to engage in high-impact work that drives innovation within the industry and contributes to improving patient outcomes globally.
Roles and Responsibilities
The Safety Scientist will play a pivotal role in ensuring product safety through a comprehensive understanding of the drug development process. Key responsibilities include:
- Pharmacovigilance Expertise: Leading safety surveillance activities, preparing and reviewing aggregate safety reports, and ensuring compliance with global pharmacovigilance regulations such as CIOMS, ICH, FDA, and EMA.
- Signal Management: Establishing and maintaining effective signal tracking processes to document signaling activities, which are essential during regulatory inspections.
- Cross-Functional Collaboration: Working closely with safety physicians and cross-functional teams, supporting clients’ investigational products, and serving as a pharmacovigilance expert.
- Quality Assurance: Carrying out quality and medical reviews of regulatory documents before submission, sharing feedback with team members, and ensuring timely deliverables without compromising quality.
Required Qualifications
Candidates should possess:
- A Master’s degree in pharmacy or a medical degree, preferably with a specialization in pharmacology.
- Extensive knowledge in patient safety, clinical development, and regulatory obligations.
- Strong analytical skills to interpret complex clinical literature and summarize findings succinctly.
- Excellent written and oral communication abilities, with keen attention to detail.
The Ideal Candidate
The ideal candidate will demonstrate a proactive approach to problem-solving, a commitment to maintaining high performance standards, and the ability to work autonomously while contributing to team goals. Familiarity with MedDRA terminology and experience with electronic databases and aggregate safety reports will be advantageous.
Benefits of Working with Synapmed
- Growth Opportunities: Synapmed is focused on fostering professional development, providing opportunities for advancement, and encouraging continuous learning within the field of drug safety.
- Work-Life Balance: As a remote position, we offer flexibility and a supportive environment that values work-life balance.
- Impactful Work: Join us in our mission to enhance patient safety, and be a part of transformative projects that have a real-world impact.
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