Are you a seasoned professional in Pharmacovigilance Quality AssuranceWe are looking for a Pharmacovigilance QA Head to lead and manage our PV QA function, ensuring excellence in compliance and quality standards. Key Responsibilities: Team Management & Oversight of following: 1. Independent quality review of ICSRs: Conduct independent quality reviews for Individual Case Safety Reports (ICSRs) with a strong understanding of the ICSR process (Must have) Oversee the quality review of aggregate reports (Preferred). 2. Quality Management System: Develop and maintain life cycle of Standard Operating Procedures (SOPs). Manage the change control system. Address process non-conformance, including investigations, root cause analyses (RCA), corrective actions, monitoring effectiveness, and trend analysis. Process improvements and implement best practices for PV QA methodologies. 3. Training Management: Maintain and update training matrices. Identify training needs and ensure the delivery of effective training programs. 4. Audit Readiness: Prepare for audits by facilitating data requests and communication for internal and health authority inspections. Respond to audit findings and implement corrective and preventive actions accordingly. 5. Compliance Monitoring & Risk Mitigation of multiple projects with defined frequency 6. Conduct Quality review meetings Experience: - 10-15 years in Pharmacovigilance Quality Assurance (PV-QA). - Preferable experience in Pharmacovigilance operations and PV-QA - Proven track record of Previous People Management. - Experience in both pharmaceutical companies and service-based organizations. Education: - Bachelor s or Master s degree in Pharmacy or a related field. Skills: - Excellent verbal and written communication. - Strong client handling abilities. - Proficient in presentation skills to effectively convey information and engage stakeholders. Why Join Us This is a unique opportunity to lead a critical function in ensuring the safety and compliance of pharmacovigilance processes. If you re passionate about quality assurance and have a proven track record of leading successful teams,.

About the Role: As a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our products comply with all applicable regulations and standards. You will work closely with various departments to prepare and submit regulatory documents, manage communications with regulatory agencies, and keep abreast of the latest regulatory requirements. Key Responsibilities: Monitoring authorities websites for updates and regulatory requirements. Creating product information, including EU Common Submission Information (EUCSI), Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and labels. Providing support for user testing of product information. Preparing dossiers for regulatory submissions, including eCTD format. Conducting compliance audits and drafting detailed audit reports. Drafting documentation for EU regulatory procedures, such as Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and Centralized Procedure (CP). Performing life-cycle maintenance tasks, including safety variations, XEVMPD updates, and preparation of protocols for user testing. Maintaining and comparing core product texts to ensure consistency and compliance. Training the team on regulatory processes and industry best practices. Undertaking any additional services mutually agreed upon in writing. Preferred Qualifications: Bachelor s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy) or a related field. Minimum of 3 years of experience in regulatory affairs, preferably within the [specific industry, e.g., pharmaceutical, medical device, biotechnology] sector. Strong knowledge of regulatory requirements and guidelines (e.g., EMA, ICH). Excellent written and verbal communication skills. Attention to detail and strong organizational skills. Ability to work independently and as part of a team. Proficiency in Microsoft Office Suite and regulatory databases.

Are you someone who can liaison between Marketing & Sales teams and seek new business opportunities by contacting and developing relationships with potential customers? You should have had prior experience in developing leads from marketing campaigns and meeting sales quotas. If you are motivated and results-driven and enjoy working in a fast-paced environment, let s meet. Your responsibilities: Perform market research to identify prospective clients Create strategies for business development by researching target demographics, economic trends, customer needs and interest areas Oversee efforts to expand lead generation through cold calling, emails and other methods Guide the business development associates to increase sales and revenue of the company Build a strong working relationship with customers to increase the potential of business opportunities Present sales pitches, product reports and other valuable data to potential prospects that helps them identify the need for the product Identify client needs and suggest appropriate products/services Study each product offered by the company and persuasively educate and inform customers of how each works and its specifications Understand how to upsell and recommend complementary merchandise Maintain potential customer accounts to generate new income and achieve sales targets Manage BD activities to achieve sales objectives and profitability Participate in trade shows, sales meetings, webinars and training sessions Develop new prospects through referrals, networking, online research and outbound calls Research and update the contact details of potential customers in customer database Prepare relevant report for various business development activities Mentor & train sales & customer service professionals about how to successfully market a product, create a need, close a sale and provide good customer support Skill sets/Experience we require: 4-6 years of relevant work experience in Business development roles/customer service/sales positions Good verbal and written communication skills Ability to deliver engaging presentations Experience reaching or exceeding weekly/monthly activity goals/quotas Hands on experience with multiple sales techniques (including cold calls) Understanding of sales performance metrics Good knowledge and experience working on MS Office Familiarity/Hands-on experience working on a CRM software is an added advantage Pedigree: Bachelor s degree in Engineering (any discipline) Master s in Business Development or related field

Key Responsibilities: Safety Signal Detection and Triage: Perform safety signal detection and triage activities for a challenging product portfolio. Identify new safety signals based on review and comprehensive medical evaluation of technical hits in post-marketing spontaneous reporting databases, analyzing single case reports as well as aggregate data available. Expert Evaluation: Provide expert evaluation of results of post-marketing signal detection activities at cross-functional team meetings, including Safety Review Meetings and Joint Safety Committees as appropriate. Collaboration: Collaborate productively with the safety leads for the respective products. Serve as a core member of the cross-functional Signal Management Team, providing expert input for post-marketing signal detection activities using internal and external spontaneous reporting databases. Database Searches and Analysis: Perform database searches in external Health Authority databases (FAERS, Vigibase, iDAP, DAEN), analyzing and reporting the results. Perform QC checks of Health Authority database searches done by colleagues. EudraVigilance Management: Manage EudraVigilance database requests, including monitoring EudraVigilance for assigned products. Provide support in training and mentoring junior Safety Signal Colleagues. Development of Guidance Documents: Drive the development and update of Business Guidance documents and SOPs. Contribute to the development of new approaches for automated signal detection in internal/external databases Qualifications: Bachelors degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences). Advanced degree preferred. Experience in pharmacovigilance, drug safety, or related field, with a focus on safety signal detection and triage. Knowledge of post-marketing spontaneous reporting databases and Health Authority databases (FAERS, Vigibase, iDAP, DAEN). Strong analytical and problem-solving skills with the ability to evaluate and interpret complex safety data. Demonstrated ability to collaborate effectively with cross-functional teams and provide expert input in a matrix environment. Experience in managing EudraVigilance database requests and conducting QC checks of database searches. Strong organizational skills with the ability to manage multiple tasks and projects simultaneously. Excellent written and verbal communication skills. Proficiency in developing and updating SOPs and Business Guidance documents.

Qualification: Bpharm/Mpharm Experience: 4-5 yrs in Drug Product regulatory affairs Job Responsibilities: should have experience in the Preparation and review of European Dossiers including 2-5 modules. Should have experience in the compilation of Module -1 Should have knowledge of EU variations Able to run independently EU procedures such as DCP and National. Working experience in eCTD is required Skills: Good written skills Knowledge in computers Good analytical skills

Vizen Lifesciences is seeking a dedicated Medical Information Call Center (MICC) Team Lead, ,Quality Reviewer, and Associates to join our team. The ideal candidate should have an educational background in B.Pharm, M.Pharm, or Nursing , with 0 to 15 years of relevant experience in a MICC environment. This role requires excellent English language skills , proficiency in understanding the US accent , and the flexibility to work in 2pm to 10 PM shift Key Responsibilities: Handle inbound and outbound calls, document them, and perform follow-up calls as per client requirements and SOPs. Ensure compliance with Vizen Lifesciences and client quality requirements. Send completed documents for QC in hourly reports. Follow telephone etiquette in the MICC process. Refer to safety reference and client-provided documents while handling calls. Manage test calls, faxes, voicemails, and emails. Categorize call information into product complaints, AE/SAE, medical queries, and product quality complaints. Forward AE/SAE information to the pharmacovigilance department and product complaints to the QA department as required. Contact manufacturing units or clients regarding medical inquiries with unavailable information. Adhere to administrative, technical, and physical safeguards to protect all data, ensuring confidentiality, integrity, and availability. Handle respective trackers and perform reconciliation. Ensure adherence to client-specific SOPs for all activities. Attend training and client meetings as needed. Provide feedback and training to team members. Archive pharmacovigilance documents. Education Qualifications requirement: Bachelors or Masters degree in Pharmacy or Nursing. Experience required: 0 to 15 years of relevant experience in Medical Information Call Center (MICC) Team Leads and ,Quality Reviewer positions require additional leadership or quality review experience Mandatory Requirement: Excellent English language speaking and writing skills.

Akshara Consultancy - Laboratory Items Distribution Company Qualifications: Bachelors degree,or masters preferably Pharmaceutics, or Pharmacology 2-3 years of sales experience, preferably in pharmaceutical laboratory items. Key Responsibilities: Sell laboratory items, including microbiology and chromatography products (HPLC/GC vials and columns). Develop and expand client relationships. Conduct regular field visits to follow up with clients and secure orders. Maintain and enhance sales performance for both existing and new business. Travel across Telangana to meet clients and ensure customer satisfaction. Desired Skills and Attributes: Strong interpersonal and communication skills. Ability to work independently and manage time effectively. Self-motivated with a proactive sales approach. Willingness to travel extensively within the region.

Key Responsibilities: Drive sales of laboratory products, particularly microbiology and chromatography items, including HPLC/GC vials and columns. Build and maintain strong relationships with clients across the assigned territory. Conduct regular client visits to follow up on leads and ensure order closures. Consistently improve sales performance by nurturing both existing accounts and identifying new business opportunities. Travel extensively within Telangana to engage with customers and ensure satisfaction. Lead and mentor a team of field sales executives, providing direction and support. Track team performance, coach team members, and help achieve set sales targets. Work closely with senior management to plan and execute region-specific sales strategies. Desired Skills & Attributes : Demonstrated ability to lead and manage sales teams effectively Strong interpersonal and communication skills A proactive and self-driven sales approach Capability to plan strategically and execute sales initiatives Flexibility and readiness to travel as required within the region Preferred Background: Experience with distribution networks or laboratory product sales will be an added advantage. Educational Qualifications : B.Sc / M.Sc in Life Sciences (Microbiology, Biochemistry, Biotechnology, Chemistry) B.Pharm / M.Pharm / Pharm.D Experience : 4 to 6 years of relevant industry experience, with exposure to similar sales roles and field management.

Work Mode: On-site (Work from Office) Key Responsibilities • Conduct independent quality reviews of Individual Case Safety Reports (ICSRs) with a strong understanding of the end-to-end ICSR process • Oversee the quality review of aggregate safety reports (preferred but not mandatory) • Develop and maintain the lifecycle of Standard Operating Procedures (SOPs) • Manage the change control system and handle deviations or non-conformances, including investigations, root cause analysis, implementation of corrective and preventive actions, and monitoring of effectiveness • Identify and implement process improvements and best practices in PV quality assurance methodologies • Maintain and update training matrices and ensure delivery of relevant and timely training programs • Prepare for audits and inspections by coordinating data requests and communication with internal teams and external authorities • Address audit findings and implement corrective and preventive actions as required • Monitor compliance and risk across multiple projects at defined intervals • Conduct regular quality review meetings and ensure documentation and follow-up on action points Desired Skills & Attributes: • Good understanding of PV quality systems, compliance processes, and regulatory expectations • Ability to independently manage quality review activities and provide constructive feedback • Strong problem-solving skills with a practical approach to handling deviations and driving improvements • Good communication skills with experience in coordinating across multiple teams • Comfortable working in a fast-paced environment with shifting priorities Preferred Background : Experience in pharmacovigilance quality assurance with exposure to both pharmaceutical companies and service-based organizations Prior experience in pharmacovigilance operations is an advantage. Educational Qualifications : Bachelors or masters degree in pharmacy or a related field. Experience :10 to 15 years of relevant experience in pharmacovigilance quality assurance Previous experience in leading or mentoring teams is preferred

Key Responsibilities Drive sales of laboratory products, particularly microbiology and chromatography items, including HPLC/GC vials and columns. Build and maintain strong relationships with clients across the assigned territory. Conduct regular client visits to follow up on leads and ensure order closures. Consistently improve sales performance by nurturing both existing accounts and identifying new business opportunities. Travel extensively within Telangana to engage with customers and ensure satisfaction. Lead and mentor a team of field sales executives, providing direction and support. Track team performance, coach team members, and help achieve set sales targets. Work closely with senior management to plan and execute region-specific sales strategies. Desired Skills & Attributes Demonstrated ability to lead and manage sales teams effectively Strong interpersonal and communication skills A proactive and self-driven sales approach Capability to plan strategically and execute sales initiatives Flexibility and readiness to travel as required within the region Preferred Background: Experience with distribution networks or laboratory product sales will be an added advantage. Educational Qualifications B.Sc / M.Sc in Life Sciences (Microbiology, Biochemistry, Biotechnology, Chemistry) B.Pharm / M.Pharm / Pharm.D