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Associate- Drug Information & Risk Management

Date: Feb 4, 2021

Location: Mumbai, MH, IN, 400083

Company: Apotex

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

 

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

1.    Coordinates the preparation/updating of Risk Management & Risk Evaluation Mitigation Plans globally including input into the medical sections of them using relevant regional templates.
2.    Active participation and discussion in Risk Evaluation and Mitigation Strategy call.
3.    Maintenance and publication of RMP’s via livelink. 
4.    Provides verbal and written responses to medical inquiries from healthcare professionals, sales representatives and other internal customers on Apotex products
5.    Demonstrates technical and scientific skills in the research and interpretation of medical information.
6.    Evaluates, analyzes and responds to medical inquiries in an accurate, balanced and timely manner
7.    Creates and peer reviews new and revised medical information documents (e.g. response documents, recall QAs, bulletins, etc.)
8.    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
9.    Ensures compliance with all SOPs pertaining to adverse event and quality complaint reporting
10.    Maintains awareness of current therapeutics and industry-based medical information regulations
11.    Provides on-call coverage as per schedule

12.    Performs other Duties as Required:
13.    Completes special medical-marketing projects as assigned
14.     Assists the in preparation of  reports 
15.     Updates/maintains product databases/files as required
16.    Works as a member of a team to achieve all outcomes.
17.     Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
18.     Performs all work in accordance with all established regulatory and compliance and safety requirements.
19.     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.

 

This is a Fixed Night Shift role (6:30 pm to 3:30 am IST)
 

 

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
 
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.