Collects, processes, and evaluates individual case safety reports (ICSRs). Performs medical coding of adverse events using MedDRA terminology. Prepares and submits expedited and periodic safety reports to authorities. Conducts literature searches for adverse event identification and assessment. Reviews patient narratives for completeness, accuracy, and medical consistency. Manages safety database (Argus, ARISg) and ensures data entry accuracy. Coordinates with clinical, medical affairs, and regulatory teams on safety matters. Prepares Periodic Benefit Risk Evaluation Reports (PBRER/PSUR) per ICH E2C. Supports signal detection and risk management plan activities. Conducts training for field force on adverse event identification and reporting. Assists with preparation for regulatory pharmacovigilance inspections. Manages case reconciliation with CROs, partners, and marketing subsidiaries. Stays updated with ICH E2A-E2F guidelines and CDSCO PV regulations.

Develops and executes the medical affairs strategy for assigned therapy areas. Builds and maintains relationships with key opinion leaders and scientific experts. Reviews and approves promotional materials for medical accuracy and compliance. Responds to medical queries from healthcare professionals and internal teams. Designs and conducts medical education programs, symposia, and advisory boards. Manages publication planning and supports scientific paper publications. Provides medical input for product launches and new indication strategies. Collaborates with clinical, regulatory, and pharmacovigilance teams. Prepares medical information letters and scientific communication materials. Conducts medical training for field force and customer-facing employees. Monitors clinical evidence and prepares medical evidence summaries. Supports health technology assessment and market access activities. Stays updated with clinical guidelines, disease area developments, and evidence.

Manages clinical trial operations across multiple study sites and protocols. Leads a team of CRAs and ensures site monitoring quality and compliance. Reviews monitoring visit reports and escalates critical findings appropriately. Manages CRO relationships and oversees third-party clinical operations. Develops site management plans, monitoring plans, and risk-based monitoring strategies. Coordinates with data management and biostatistics teams for data review. Ensures timely submission of clinical study reports and regulatory filings. Manages study budgets, site payments, and milestone tracking systems. Leads inspection readiness programs for regulatory authority audits. Prepares and delivers training for CRAs on protocols and GCP compliance. Manages trial master file completeness and archival for completed studies. Supports business development by reviewing clinical feasibility for new studies. Stays current with adaptive trial designs, CDSCO regulations, and GCP updates.

Monitors clinical trial sites to ensure compliance with ICH-GCP guidelines. Conducts site initiation visits, routine monitoring visits, and close-out visits. Reviews source documents and case report forms for accuracy and completeness. Identifies and resolves protocol deviations and data discrepancies at sites. Maintains accurate monitoring visit reports and site communication logs. Ensures informed consent process is properly conducted at all study sites. Manages investigational product accountability and temperature records. Coordinates with principal investigators and site staff for study conduct. Tracks patient enrollment and ensures recruitment targets are met on time. Manages trial master file (TMF) and ensures inspection readiness at all times. Supports serious adverse event (SAE) reporting and safety data management. Prepares escalation reports for protocol violations and major deviations. Stays updated with ICH E6 R2, CDSCO CT rules, and regulatory requirements.

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.

Leads formulation development team for oral, topical, and parenteral products. Develops R&D strategy aligned with the company's new product pipeline. Reviews and approves formulation development reports and protocols. Manages project timelines, resources, and deliverables for R&D pipeline. Leads technology transfer activities from R&D to commercial manufacturing. Provides formulation expertise and guidance for ANDA and NDA dossier filings. Coordinates with regulatory affairs for technical sections of drug submissions. Manages CRO and CMO relationships for outsourced formulation development. Oversees pilot plant operations and scale-up activities. Establishes quality by design framework for new product development programs. Mentors junior scientists and builds technical capabilities in the R&D team. Manages R&D budget and ensures cost-effective product development. Stays current with novel drug delivery systems, CDMO partnerships, and regulatory trends.

Develops pharmaceutical formulations for oral solid dosage forms including tablets and capsules. Conducts preformulation studies including solubility, polymorphism, and compatibility. Designs and executes formulation optimization experiments using DoE approaches. Prepares lab-scale and pilot-scale batches for stability and clinical studies. Conducts in-vitro dissolution studies and analyses release profiles. Prepares development reports, formulation records, and batch manufacturing records. Supports technology transfer of formulations to manufacturing scale. Collaborates with QC for analytical method development during formulation work. Investigates formulation failures and proposes corrective strategies. Stays updated with literature on excipients, polymers, and novel drug delivery. Supports regulatory filing by providing formulation data for drug dossiers. Maintains laboratory safety and GLP compliance in all development activities. Stays current with ICH Q8, Q9, Q10 guidelines and Quality by Design principles.

Leads quality control laboratory operations across raw material, in-process, and finished goods. Manages a team of QC analysts, scientists, and laboratory technicians. Oversees method development, validation, and transfer for all analytical methods. Ensures laboratory equipment qualification, calibration, and maintenance programs. Reviews and approves analytical data, QC release, and stability protocols. Manages OOS/OOT investigations and ensures timely resolution. Leads laboratory audit readiness and manages responses to inspector observations. Oversees reference standard management and reagent control programs. Ensures LIMS system integrity and data integrity compliance across laboratory. Manages stability study programs and prepares annual stability reports. Coordinates with production, QA, and procurement teams on quality matters. Prepares QC section for regulatory submissions and product dossiers. Stays current with USP, BP, ICH Q2R1, and regulatory data integrity guidance.

Performs chemical and physical testing of raw materials, in-process, and finished products. Operates analytical instruments including HPLC, GC, UV-Vis, and IR spectrophotometers. Prepares reference standards, reagents, and mobile phases for analytical testing. Records test results accurately in laboratory notebooks and LIMS systems. Investigates OOS and OOT results and prepares investigation reports. Maintains calibration and qualification records for all analytical instruments. Performs microbiological testing including bioburden, sterility, and LAL testing. Ensures compliance with pharmacopoeial standards including IP, BP, and USP. Reviews analytical methods and assists in method development and validation. Manages stability testing samples and prepares stability reports. Follows GLP guidelines and maintains clean and organized laboratory workspaces. Supports internal and regulatory inspections with documentation and data. Stays updated with pharmacopoeial updates and analytical technology advances.

Leads quality assurance function for one or more manufacturing sites. Responsible for GMP compliance across all manufacturing and support functions. Manages preparation and submission of responses to regulatory authority observations. Oversees change control, deviation management, and CAPA closure programs. Reviews and approves all critical quality documents and batch release decisions. Leads regulatory inspections including US-FDA, EU-GMP, and WHO pre-qualification. Develops and implements quality improvement initiatives across the site. Manages vendor qualification programs and third-party manufacturing compliance. Ensures validation lifecycle management for equipment, processes, and cleaning. Prepares site quality metrics and KPIs for management review meetings. Manages annual product quality review and product quality management systems. Mentors QA executives and builds team capability in quality management. Stays current with regulatory guidances, warning letters, and inspection trends.