Senior Drug Safety Associate
Location: Pune, Maharashtra, India
Job Type: Full-time
Department: Clinical & Medical
Job Family: Pharmacovigilance
Company Overview
At EVERSANA, we take pride in being recognized as a Great Place to Work globally. Our vision is to create a healthier world through our dedicated team of over 7,000 employees. We provide next-generation commercialization services to the life sciences industry, partnering with more than 650 clients, from innovative biotech startups to established pharmaceutical companies. Our services help bring groundbreaking therapies to market and support the patients who rely on them. Together, we strive to make a positive impact every day.
We value diversity in backgrounds and experiences, and improving patient lives worldwide is our top priority. We seek individuals from all walks of life to help shape the future of healthcare and the life sciences industry. Our inclusive culture thrives on strong teamwork and a deep commitment to our clients and the patients we serve.
Position Overview
As a Senior Drug Safety Associate, you will play a crucial role in supporting our client's Pharmacovigilance (PV) Department. This position involves both team collaboration and individual contributions to process and analyze safety data from clinical trials and post-marketing reports.
Key Responsibilities
Collaborate with PV Management and Project Managers to meet project deadlines.
Support PV Associate staff in managing workload and ensuring timely regulatory reporting.
Participate in case processing activities and the development of PV documents, including aggregate reports and SOPs.
Collect and track Adverse Events (AEs) from various sources, ensuring accurate reporting.
Independently assess reportability of AEs, working with team members to establish clinical assessments.
Code adverse events using MedDRA and medications to WHODRUG.
Perform Quality Control checks for completeness and accuracy of safety data.
Draft narratives of reported events, ensuring clear and concise communication.
Formulate follow-up queries independently and assist in information exchange with clients.
Maintain compliance with regulatory timelines for expedited case reports.
Develop expertise in assigned client products within therapeutic areas and understand relevant regulations and guidelines.
Lead and mentor team members to facilitate efficient case processing.
Conduct periodic reconciliation of SAEs between drug safety and clinical trial databases.
Qualifications
Education: BS degree in a life science discipline (e.g., pharmacy, nursing) preferred.
Experience: Minimum of 5 years of relevant experience, including 3 years in drug safety.
Knowledge: Broad understanding of domestic and international drug safety regulations and industry practices.
Skills: Strong attention to detail, teamwork, planning, and organizational abilities.
Technical: Proficiency with safety databases and Microsoft Office, and familiarity with MedDRA and WHODRUG coding.
Personal Attributes
Positive Attitude: Displays an upbeat demeanor and genuine interest in others.
Communication Skills: Effectively articulates ideas and fosters a collaborative environment.
Innovative Thinking: Generates creative solutions that enhance company performance.
Integrity: Demonstrates high moral and ethical standards in all actions.
Additional Information
All candidate information will be kept confidential in accordance with EEO guidelines. Please be aware of recent fraudulent job offers misrepresenting EVERSANA. We will never request personal information or payment during the recruitment process.
At EVERSANA, Diversity, Equity, and Inclusion are integral to our success. We are an Equal Opportunity Employer and celebrate the unique strengths and experiences of our employees. Inclusion is a shared responsibility, and every perspective contributes to our mission of improving patient lives.
Join us at EVERSANA and make a meaningful impact in the healthcare industry!
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