Associate/Sr Associate, Medical Affairs (Pharmacovigilance)
Apotex
Mumbai, Maharashtra
Job Summary

Part of multi-disciplined team of healthcare professionals who support Apotex products (domestic and international) by coordination of the development of medical documents such as Risk Management & Risk Evaluation Mitigation Plans, informing internal and external customers of the safe and effective use of drugs manufactured and marketed by Apotex Inc. and their affiliates/distributors worldwide by providing professional, unbiased, clinically relevant and timely medical information.

Job Responsibilities

Coordinates the preparation/updating of Risk Management & Risk Evaluation Mitigation Plans globally including input into the medical sections of them using relevant regional templates.
Active participation and discussion in Risk Evaluation and Mitigation Strategy call.
Maintenance and publication of RMP’s via livelink.
  • Provides verbal and written responses to medical inquiries from healthcare professionals, sales representatives and other internal customers on Apotex products
  • Demonstrates technical and scientific skills in the research and interpretation of medical information.
  • Evaluates, analyzes and responds to medical inquiries in an accurate, balanced and timely manner
  • Creates and peer reviews new and revised medical information documents (e.g. response documents, recall QAs, bulletins, etc.)
  • Participates in departmental and cross-functional business teams by supporting team initiatives and contributing directly or indirectly to team goals/projects based on priority to the business
  • Ensures compliance with all SOPs pertaining to adverse event and quality complaint reporting
  • Maintains awareness of current therapeutics and industry-based medical information regulations
  • Provides on-call coverage as per schedule
  • Performs other Duties as Required:
Completes special medical-marketing projects as assigned
Assists the in preparation of reports
Updates/maintains product databases/files as required
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
Perform all other duties and special projects and after-hour coverage of GMA unit as assigned.
Job Requirements

B.Sc., or Diploma in Health/Science related discipline
Minimum 2 years pharmaceutical experience preferably in a clinical, regulatory, medical or Pharmacovigilance role
Excellent oral/written communication in English; bilingual preferred
Knowledge of Microsoft office software: Excel, PowerPoint, Word, Outlook, etc.
Knowledge of IRMS, MedDRA and online literature searching preferred
Excellent organizational & interpersonal skills; experience in working in a dynamic team environment
Knowledge of GMP, GCP, relevant global regulations and ICH guidelines on safety data management in patient registries, RMPs/REMS and post-approval PV.