Biocon Biologics is a pioneering company in the biosimilars revolution, dedicated to making high-quality, affordable biosimilars accessible to patients worldwide. With a mission to impact a billion lives, Biocon Biologics fosters a culture of innovation, patient-centricity, and disruptive thinking. The company is currently seeking a Drug Safety Specialist in Bengaluru, Karnataka, India, to join their Safety Surveillance and Risk Management team.
What Does a Drug Safety Specialist Do?
A Drug Safety Specialist plays a crucial role in ensuring the safety and efficacy of pharmaceutical products. At Biocon Biologics, this role involves:
- Safety Signal Management: Overseeing the process of detecting, tracking, and evaluating safety signals from various data sources.
- Risk Management Plans (RMP): Preparing and maintaining RMPs, including risk minimization measures and monitoring their effectiveness.
- Aggregate Reporting: Managing the scheduling, preparation, and submission of aggregate reports like Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
- Regulatory Compliance: Ensuring compliance with global pharmacovigilance regulations (ICH, Eudravigilance, etc.) and responding to safety queries from regulatory authorities.
- Cross-functional Collaboration: Working closely with internal teams (clinical development, medical affairs, regulatory) and external partners to ensure drug safety.
Key Responsibilities of a Drug Safety Specialist at Biocon Biologics
1. Safety Signal Management
- Set up processes for periodic signal detection.
- Evaluate safety data and author signal evaluation reports.
- Conduct literature reviews for safety information.
2. Risk Management Plans (RMP)
- Develop and maintain RMPs for assigned products.
- Monitor the effectiveness of risk minimization measures.
3. Aggregate Reporting
- Oversee vendors for aggregate report preparation and submission.
- Ensure compliance with regulatory timelines and quality standards.
4. Regulatory and Partner Collaboration
- Respond to safety questions from regulatory authorities and partners.
- Support pharmacovigilance audits and inspections.
5. Process Improvement
- Lead initiatives to improve processes related to signal management, RMPs, and aggregate reporting.
6. Documentation and Compliance
- Prepare SOPs and working guidance documents.
- Ensure adherence to good pharmacovigilance practices (GVP).
Qualifications and Skills Required
To excel as a Drug Safety Specialist at Biocon Biologics, candidates should possess:
- Educational Background: A Master’s degree or higher in Life Sciences, Pharmacy, or Healthcare. Alternative Medicine, BDS, or PhD qualifications are also acceptable.
- Experience: Minimum of 5 years in pharmacovigilance, with at least 3 years in aggregate reporting, safety signal management, and RMPs.
- Industry Knowledge: Understanding of biopharmaceutical industry guidelines, regulations, and best practices.
- Technical Skills: Proficiency in MS Office tools (Excel, PowerPoint, Word).
- Soft Skills: Strong communication, organizational, and leadership skills. Ability to work collaboratively in a team environment.
Why Join Biocon Biologics?
Biocon Biologics offers a dynamic and multicultural work environment where employees are driven by a shared purpose to improve global healthcare. By joining the team, you will:
- Impact Lives: Contribute to making affordable biosimilars accessible to patients worldwide.
- Grow Professionally: Work with industry experts and gain exposure to cutting-edge pharmacovigilance practices.
- Innovate: Be part of a company that values disruptive thinking and patient-centric innovation.
