Drug Safety Associate

Company Description

Since 2007, Global IT Solutions has been a leading strategic manpower sourcing agency, specializing in placements for IT and ITES companies across India. Our team consists of highly experienced recruiters with extensive knowledge in various business domains. We have consistently demonstrated a success rate ranging from 70% to 80% in delivering outstanding results. Our agency plays a pivotal role in facilitating the successful placement of highly qualified candidates throughout India.

Role Description

This is a full-time on-site role for a Drug Safety Associate located in Navi Mumbai. The Drug Safety Associate will be responsible for monitoring and ensuring the safety of pharmaceutical drugs. Day-to-day tasks include preparing and reviewing narrative reports, performing quality control, regulatory affairs activities, managing pharmacy-related tasks, and conducting medical coding.

Educational Qualifications:

Mandatory Requirements: MBBS (Bachelor of Medicine, Bachelor of Surgery), OR MD (Doctor of Medicine) Additional Requirement for Foreign Graduates FMGE (Foreign Medical Graduate Examination) certification is mandatory for candidates who have completed their medical degree outside India Job Summary We are seeking a qualified Drug Safety Physician/Medical Reviewer to join our Pharmacovigilance team. The ideal candidate will be responsible for reviewing biomedical literature, assessing adverse drug reactions, and ensuring compliance with regulatory guidelines in drug safety reporting. This role requires strong medical knowledge, attention to detail, and the ability to work collaboratively in a fast-paced pharmaceutical environment. Key Roles & Responsibilities 1. Literature Review & Case Assessment Review published reports and biomedical literature to identify case reports of adverse reactions and nonindividual case reports Evaluate medical and scientific literature for potential safety signals Extract relevant safety information from various sources including journals, databases, and regulatory publications 2. Regulatory Compliance Apply regulatory guidelines and internal SOPs to determine if articles meet the definition of case reports and non-individual case reports Ensure all assessments comply with international pharmacovigilance standards (FDA, EMA, ICH guidelines) Maintain up-to-date knowledge of evolving regulatory requirements 3. Relevancy Assessment Perform relevancy assessment based on accepted industry guidelines and standards Evaluate the clinical significance and reportability of adverse events Determine causality assessment using standardized scales and algorithms 4. Training & Mentorship Provide training and guidance to literature scanners on inclusion criteria for case reports and non-individual case reports Support junior team members in understanding pharmacovigilance concepts and processes Contribute to the development of training materials and SOPs 5. Quality & Collaboration Work closely with Subject Matter Experts (SMEs) to ensure the physician team maintains necessary skills per industry norms Participate in quality control activities and process improvement initiatives Collaborate with cross-functional teams including safety scientists, regulatory affairs, and medical affairs 6. Additional Responsibilities Perform additional tasks and responsibilities as assigned or delegated by the Team Lead/Manager Participate in team meetings, audits, and regulatory inspections as required Maintain accurate documentation and audit trails for all assessments Technical & Functional Competencies Core Competencies:

1. Regulatory Knowledge Sound knowledge of regulatory guidelines related to Pharmacovigilance (PV) domain Understanding of ICH E2A, E2B, E2C, E2D, E2E guidelines Familiarity with country-specific regulations (FDA, EMA, CDSCO)

2. Medical Writing Skills Proficiency in narrative writing for case reports Ability to write clear, concise, and medically accurate documentation Experience in preparing Individual Case Safety Reports (ICSRs)

3. Medical Coding Expertise in MedDRA (Medical Dictionary for Regulatory Activities) coding Knowledge of WHO-ART and other coding dictionaries Understanding of coding hierarchy and terminology

4. Pharmacological Knowledge Strong familiarity with pharmacological concepts and principles Understanding of drug mechanisms, interactions, and adverse effects Knowledge of therapeutic areas and disease pathology

5. Communication Skills Excellent command of verbal and written communication in English Ability to present complex medical information clearly Strong interpersonal skills for cross-functional collaboration

6. Team Collaboration Proven ability to work effectively as a team player Collaborative approach to problem-solving.

Willingness to support and mentor colleagues Required Knowledge Areas Pharmacovigilance Fundamentals Comprehensive understanding of Pharmacovigilance (PV) principles and practices Signal detection methodologies and data mining techniques Causality assessment skills (WHO-UMC scale, Naranjo algorithm, etc.) Individual Case Safety Report (ICSR) processing and submission Drug Safety Concepts Assessment of adverse event seriousness and severity Understanding of medication errors and their classification Knowledge of off-label drug use, drug abuse, and drug misuse Aggregate safety reporting (PSURs, PADERs, DSURs) Regulatory Framework Familiarity with regulatory authorities for pharmacovigilance in India (CDSCO, IPC) Understanding of international regulatory bodies (FDA, EMA, MHRA) Knowledge of Important Medical Events (IME) and Designated Medical Events (DME) lists Difference between IME and DME classifications Clinical & Therapeutic Knowledge Drug labeling sections and requirements Common antibiotics and their therapeutic applications Drugs used for off-label treatment during COVID-19 pandemic Side effects of steroids and other commonly used medications Application of drugs in clinical practice.

Qualifications

• Narrative and Medical Coding skills
• Quality Control and Regulatory Affairs experience
• Pharmacy-related skills
• Strong analytical and problem-solving abilities
• Excellent written and verbal communication skills
• Bachelor's degree in Pharmacy, Life Sciences, or a related field
• Prior experience in drug safety or pharmacovigilance is a plus