Evaluates safety and toxicological profiles of drug candidates and excipients. Reviews toxicology study designs and coordinates preclinical safety studies. Prepares toxicology summaries and safety assessments for regulatory submissions. Evaluates genotoxicity, carcinogenicity, and reproductive toxicology data. Assesses impurity limits using ICH Q3A, Q3B, Q3C, and Q3D guidelines. Conducts extractables and leachables assessments for container closure systems. Prepares investigator brochures with integrated non-clinical safety data. Supports calculation of starting doses for first-in-human clinical studies. Provides toxicology expertise for risk assessment of manufacturing occupational exposure. Reviews and prepares non-clinical sections of CTD for regulatory submissions. Evaluates safety data from literature for novel excipients and formulation aids. Provides safety assessment for combination products and drug-device products. Stays current with ICH M7, S1-S9 guidelines, and global toxicology regulations.

Develops and validates analytical methods for drug substances and drug products. Conducts analytical method validation per ICH Q2R1 guidelines. Performs forced degradation studies to identify degradation pathways. Develops stability-indicating methods for all dosage forms. Supports technology transfer of analytical methods to QC laboratories. Operates and maintains HPLC, UPLC, GC, LC-MS/MS, and ICP-MS instruments. Prepares analytical sections of regulatory dossiers and CMC modules. Investigates analytical method failures and out-of-specification results. Collaborates with formulation scientists during preformulation studies. Ensures compliance with data integrity and 21 CFR Part 11 requirements. Manages reference standards and maintains analytical reagent inventory. Supports regulatory inspections with analytical data and laboratory documentation. Stays updated with pharmacopoeial changes, ICH guidelines, and analytical innovation.

Promotes pharmaceutical products to doctors, hospitals, and chemists. Achieves monthly sales targets and coverage for assigned territory. Conducts regular detailing calls to physicians in specialty areas. Organizes and participates in CMEs, product launches, and camps. Builds and maintains long-term relationships with key prescribers. Reports competitor activities and market intelligence to management. Manages sample and promotional material inventory responsibly. Processes orders and ensures timely supply to stockists and retailers. Submits daily call reports and activity logs in CRM system. Participates in product training and knowledge assessments. Addresses doctor queries on product efficacy and safety. Implements marketing campaigns and promotional strategies in territory. Achieves new product launch targets within defined timelines.

Position: Senior Clinical Data Manager An exceptional opportunity has arisen for a talented Senior Clinical Data Manager to contribute to our mission. The successful candidate will be part of a collaborative, high-performance environment committed to excellence. Core Responsibilities: Participate in regulatory inspections, health authority meetings, and internal audits. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Minimum Qualifications: Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Superior writing and communication skills with experience preparing executive-level documents. Collaborative, proactive, and able to operate effectively with minimal supervision. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We offer a competitive remuneration package commensurate with experience and market standards. Qualified candidates are encouraged to apply.

Position: Clinical Data Manager We invite a proactive and capable Clinical Data Manager to lead and execute within a collaborative, agile environment. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Key Responsibilities: Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Support collection and review of adverse event safety data from clinical and post-market sources. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Ensure all cases are coded and processed per MedDRA and applicable global standards. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Conduct structured literature reviews and contribute to scientific summaries and labelling. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Qualifications and Requirements: Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Experience collaborating within cross-functional teams and matrix organisational structures. Minimum 35 years of progressive professional experience in a comparable role. Excellent verbal and written communication skills; fluency in English is essential. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. A competitive compensation structure along with performance incentives and growth opportunities awaits the right candidate.