Are you passionate about contributing to the healthcare industry through pharmacovigilance? Continuum, a leading contract research organization based in Chandigarh, India, is hiring for the position of Pharmacovigilance Scientist. This is a fantastic opportunity to work with a team dedicated to ensuring the safety and efficacy of pharmaceutical and consumer products.
About Continuum
Continuum is a premier contract research organization (CRO) offering comprehensive services, including regulatory support, pharmacovigilance, clinical data management (CDM), statistical programming, evidence evaluation, and technology solutions. With a focus on planning, product launch, and lifecycle management, Continuum serves the pharmaceutical, consumer products, and medical device sectors.
Responsibilities in the Role
As a Pharmacovigilance Scientist, you will be responsible for various critical tasks, including:
- Case Management:
- Processing Individual Case Safety Reports (ICSRs) for adverse events (AEs) and serious adverse events (SAEs).
- Ensuring compliance with applicable regulatory requirements for both human and veterinary products.
- Aggregate Reporting:
- Preparing periodic and unscheduled reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), PSURs, US Periodic Adverse Drug Experience Reports (PADERs), and Signal Evaluation Reports (SERs).
- Performing quality checks on aggregate reports.
- Signal Detection:
- Conducting cumulative and issue-event analyses for signal detection and evaluation.
- Preparing comprehensive signal-related reports.
- Regulatory Compliance:
- Maintaining a thorough understanding of global regulatory reporting obligations.
- Ensuring adherence to internal and external reporting timelines.
- Collaboration and Communication:
- Interacting with internal and external stakeholders to resolve issues related to safety reports and regulatory compliance.
- Staying updated on the adverse event profiles and safety regulations for assigned products.
Qualifications
- A Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, etc.) or a Bachelor/Postgraduate degree in Veterinary Sciences.
- A Dentistry qualification (BDS/MDS) is an added advantage.
- Previous experience in pharmacovigilance or drug safety is desirable.
Skills Required
Team-oriented mindset with the ability to handle flexible work priorities.
Strong knowledge of medical terminology.
Proficiency in web-based applications, Windows OS, and MS Office (Word, Excel, PowerPoint).
Excellent written and spoken English communication skills.
Strong analytical and evaluation capabilities to interpret data and draw conclusions.
Ability to write clear, concise, and relevant medical texts.
Exceptional attention to detail and accuracy in documentation.
How To Apply
write to us at careers@continuumindia.com
