Team Leader- Pharmacovigilance, PV, PSRM, Aggregate Reports, RMP

Date: Nov 13, 2020

Location: Mumbai, MH, IN, 560083

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 Responsibilities
  • Prepares and conducts peer review of periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
  • Performs Signal detection/management activities in accordance with internal procedures and regulatory guidelines/requirements.
  • Assists in the preparation/review of Risk Management plans.
  • Develops and maintains SOPs.
  • Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology.
  • Performs all work in accordance with all established ICH guidelines, regulatory compliance and safety requirements and maintains current knowledge on all relevant Pharmacovigilance regulations.
  • Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion; and
Job Requirements
    • Experience: Core PV experience of at least 3-5 years in drafting/writing Aggregate Reports like PADERs, PSURs, CARs, PBRERs.
    • Qualifications: MBBS with 4 to 7 yrs experience in a PSRM, signal detection, risk management role.
  • Knowledge, Skills and Abilities
    • Excellent analytical and problem-solving skills
    • Excellent oral/written communication in English.
    • Knowledge of MedDRA, Oracle ARGUS & online literature searching preferred
    • Excellent organizational & interpersonal skills; experience in working in a dynamic team environment
    • Excellent knowledge of relevant local and international regulations and ICH guidelines on safety data management in clinical trials and post-approval
    • Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word



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.