As a Drug Regulatory Affairs Manager at Covalent, you will be responsible for leading the Global Regulatory Project Team, comprising internal team members and external partners, to ensure the planning, preparation, and delivery of both simple and complex regulatory submissions and response documents on a global and regional scale. This includes maintaining core labeling documents, corporate approval of EU SmPC and US PI, and ensuring consistency with internal standards and SOPs. Your role will involve liaising with internal functions and external partners, leading cross-functional delivery teams, identifying regulatory risks, supporting routine and non-routine interactions with health authorities, and monitoring changing regulatory legislation. You may also serve as a delegate for the Global Regulatory Lead and provide coaching, mentoring, and training within the Regulatory team. To qualify for this position, you should have a University Degree in Science or a related discipline, along with 6-12 years of relevant regulatory experience in license maintenance, labelling, and working across various markets. Leadership skills, excellent English communication skills, and a thorough understanding of the regulatory product maintenance process are essential. Experience in working with diverse teams, especially in Europe and the USA, is preferred. Key skills and capabilities required for this role include supplier and partner management, project management, influencing, problem-solving, independence, teamwork, customer focus, and a commitment to continuous improvement. If you are passionate about regulatory affairs and possess the necessary qualifications and experience, we encourage you to share your profile with us at contact@covalenttrainings.com or contact us at +91-9848733309 / +91-9676828080 for further guidance. Join us at Covalent and contribute to maintaining regulatory compliance while fostering strong partnerships with internal and external stakeholders.,
You will be responsible for performing various activities on behalf of the Marketing Authorization Holder. Your main responsibilities will include maintaining oversight of the Pharmacovigilance (PV) system in all relevant aspects, such as SOPs & Training, contractual arrangements, databases, compliance data, audit/inspection plans, PV systems of local affiliates, and ensuring that all PV processes are conducted in accordance with pertinent regulations. Additionally, you will oversee the preparation and maintenance of the PV System Master File, maintain an overview of safety profiles and any emerging safety concerns of all Marketing Authorization Holder products, manage the signal management process to identify possible safety signals, ensure awareness and appropriate fulfillment of CA queries and commitments, develop Risk Management Plans, and Periodic Safety Update Reports (PSUR). You will have input into the risk-based audit of the PV system, manage members of the QPPV Office, carry out continuous overall pharmacovigilance evaluation of the drug post-marketing, perform literature surveillance activity for all Marketing Authorization Holder products, and manage vendors for pharmacovigilance related work. This internship opportunity in Pharmacovigilance is for a duration of either 6 months or 1 year, and it is a paid internship. The salary will be as per company norms. The industry is Pharma/Biotech/Clinical Research, and the functional area includes Medical, Healthcare, R&D, Pharmaceuticals, and Biotechnology. The role category is Drug Regulatory Affairs/Documentation, and the specific role is Documentation/Medical Writing as an Intern. This position is an Intern to Hire employment type, and the qualification required is any Life Science graduate. If you are interested, you can forward your profile to contact@covalenttrainings.com or reach out for guidance at +91-9848733309 / +91-9676828080.,
Job Summary: - We are seeking an experienced and knowledgeable Medical Coding Trainer to join our Covalent team. The Medical Coding Trainer will be responsible for developing and delivering comprehensive training programs for aspiring medical coders. The ideal candidate will have a strong background in medical coding, a passion for teaching, and the ability to convey complex information in an easily understandable manner. Key Responsibilities: - Training Development: Design and update training materials, manuals, and online resources for medical coding courses. Develop curriculum that covers current medical coding practices, industry standards, and regulatory requirements. Instruction: Conduct classroom, online, and one-on-one training sessions. Provide instruction on medical coding systems such as ICD-10, CPT, and HCPCS. Use a variety of teaching methods to accommodate different learning styles. Assessment and Evaluation: Assess trainees coding skills and knowledge through exams, practical assignments, and interactive activities. Provide constructive feedback and support to help trainees improve their coding abilities. Industry Updates: Stay current with changes in medical coding guidelines, healthcare regulations, and industry best practices. Communicate updates and changes to trainees and incorporate them into training materials. Mentorship and Support: Mentor and support trainees throughout their learning journey. Address individual trainee questions and concerns in a timely and effective manner. Administrative Duties: Maintain accurate records of training sessions, trainee progress, and certification results. Coordinate training schedules and logistics with the administrative team. Qualifications: - Education: Bachelors degree in Health Information Management, Medical Coding, or a related field preferred. Certified Professional Coder (CPC) or Certified Coding Specialist (CCS) certification required. Experience: Minimum of 8-12 years of professional experience in medical coding. Prior experience in a training or educational role preferred. Skills: In-depth knowledge of ICD-10, CPT, and HCPCS coding systems. Excellent communication and presentation skills. Strong organizational and time-management abilities. Proficient in using training software and online educational tools. Ability to adapt teaching methods to different learning styles. Certifications: Certified Professional Coder (CPC) Certified Coding Specialist (CCS) Certified Inpatient Coder (CIC) Certified Outpatient Coder (COC) AHIMA or AAPC certification Knowledge: ICD-10-CM/PCS CPT/HCPCS Medical Terminology Anatomy and Physiology Health Information Management (HIM)