Job Summary: We are seeking a highly motivated and detail-oriented Clinical Affairs Specialist with strong experience in post-market surveillance, Post-market Clinical Follow-up (PMCF), Periodic Safety Update Reports (PSUR), clinical evaluation under MDR, and health complaint assessment within the pharmaceutical and medical device industry . The ideal candidate will support regulatory compliance and safety monitoring in alignment with US FDA, EU MDR and relevant global regulatory standards. Key Responsibilities: Prepare and manage Post-Market Surveillance (PMS) activities for pharmaceutical and medical device products. Prepare and update Post-market Clinical Follow-up (PMCF), Periodic safety update report (PSUR) in compliance with EU MDR and other relevant regulations. Conduct and compile Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) as per MDR (EU) 2017/745 requirements. Review, assess, and investigate health complaints, adverse events, and product safety issues. Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, and other relevant department. Maintain up-to-date knowledge of global regulatory requirements related to PMS, PMCF, PSUR, and clinical evaluations. Support audits and inspections related to PMS, PMCF, PSUR, and health complaint documentation. Ensure accurate documentation and timely submission of regulatory reports. Other tasks as assigned by management. Qualifications & Requirements: Bachelor's or Masters degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field. Minimum 5-7 years of experience in clinical affairs, regulatory affairs, or related function in the pharmaceutical or medical device industry. In-depth understanding of EU MDR (2017/745), ISO 14155, and applicable regulatory guidelines. Strong experience with PSUR preparation, PMS plans/reports, and clinical evaluation documentation. Familiarity with health complaint management systems and risk assessment methodologies. Excellent written and verbal communication skills. Ability to work independently and manage multiple projects. Preferred Skills: Experience working with Notified Bodies and regulatory agencies. Prior involvement in MDR transition projects. Knowledge of pharmacovigilance and medical device vigilance systems
NeilMed Pharmaceuticals is a leading manufacturer in nasal saline OTC(over the counter) products. We are committed to providing exceptional customer service and satisfaction. We ensure that our products meet the highest level of quality and safety standards. We're constantly looking for experienced, self motivated, hard working, and dependable individuals to join our rapidly growing company. This position is NIGHT SHIFT only. We are looking for a skilled Call center representatives to work from office . We do not provide transportation and food. Roles and Responsibilities Developing objectives for the day-to-day activities Addressing customer queries, resolving issues, and providing information. roles involves outbound sales activities also Should have experience in voice process inbound and outbound calls to doctors, medical professionals and customers related to products and general enquiry. Identify the needs of customers, resolve issues, and provide solutions and maintain good customer relations. Respond to dissatisfied customers, and problem-solving skills Maintain records of the conversations with the customer and analyse the data Input into the company application platform to keep each customer record updated. Build sustainable relationships with the team. Must be excellent in E-mail and writing skills as you will be interacting with international customers. Working hours would be purely night shift with any 5 days in a week working. Use company policies to determine if there can be an immediate resolution to a customer issue or if that issue requires managerial input. Need to know priority measures and handle the issues professionally. must be an organized, reliable and results-driven professional. must have excellent customer service and communication skills. Desired Candidate Profile 1+ years experience in telemarketing / outbound call center environment Excellent verbal and written communication skills are crucial for all roles Experience in customer service, sales, or related fields is often required. Computer literacy and familiarity with call center software or CRM tools . we are looking for candidates who can join us immediately or latest within 15days. Customer focus and adapt to different personality types to work in a team. Be a strong team player with pleasant attitude with responsiveness. Good knowledge of excel is a must. Flexibility in shifts, offs & working hours. ' Bachelors Degree Outstanding communication and interpersonal skills Perks and Benefits We have been operational for more than 16 yrs plus and job security is a key point. Looking for male candidates as it is purely night shift and we do not provide food and transport.
NeilMed Pharmaceuticals, Inc.s Staff Accountant requires a strong accounting background with 3 - 5 years experience with a solid understanding of GAAP reporting requirements and excellent Excel skills. He/she must have a broad base of technical experience in addition to accounting skills. Some management experience is important where the individual has demonstrated the ability to meet a wide variety of rapidly changing challenges. Role & responsibilities Monitor pricing schedule to ensure customers orders reflect current pricing based on effective dates. Prepare monthly account reconciliations of GL balance sheet accounts Update and maintain Fixed Asset sub-ledger system & post depreciation entries Prepare monthly and quarterly Sales Tax, Use Tax, GST & VAT tax returns Assist in the preparation on International financial statements Prepare audit and bank schedules as needed Prepare journal entries to properly amortize Prepaid Expenses & other adjusting entries as needed Assist in the development of accounting and financial polices and procedures to ensure the efficient financial operations of the organization and ensure compliance with applicable accounting and financial standards Complete adhoc requests and projects as assigned Handle other responsibilities as requested by the CEO, Finance head or company management Preferred candidate profile Should have completed CA. Three to five years of demonstrated accounting experience in a dynamic, fast-paced environment Working knowledge of International GAAP and GL processing Bachelors degree in Accounting, CA/ACCA Qualified, • Excellent written and oral communication skills to document processes and procedures • Professionalism, maturity and strong organizational skills Keen ability to focus, anticipate needs, maintain close attention to detail, and prioritize work within a fast-paced environment. Ability to work independently to meet goals with limited supervision • Skilled in preparing financial analysis, financial statements, and financial reports. • Excellent Excel skills with knowledge of pivot tables. • Ability to work on multiple projects simultaneously
Role & responsibilities : Proven experience as an office administrator , office assistant or relevant role Excellent organizational and leadership skills Familiarity with office management procedures and basic accounting principles Coordinate office activities and operations to secure efficiency and compliance to company policies Supervise housekeeping staff and divide responsibilities to ensure performance and clean office atmosphere for staffs to work Manage agendas/travel arrangements/appointments etc. for the upper management Manage vendors Support in recruitment and joining formalities Management of attendance and breaks of employees Create and update records and databases with personnel, financial and other data Track stocks of office supplies and place orders when necessary Submit timely reports and prepare presentations/proposals as assigned Assist colleagues whenever necessary Organising internal and external events Desirable attributes for the ideal candidate : Great organizational skills Multitasking abilities Excellent written and verbal communication skills Excellent problem solving and critical thinking skills, Ability to handle complex and confidential information professionally Good writing skills & typing skills Time management Excellent interpersonal skills Project management skills Excellent knowledge of MS Office and office management software (ERP etc.) Detail-oriented Ability to work quickly and effectively Ability to stay calm under pressure Flexibility in timing when needed.