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Deputy Manager - Global Pharmacovigilance (Mumbai)

Date: Dec 30, 2020

Location: Mumbai, MH, IN, 400079

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

Performs global Pharmacovigilance processes of the unit: Medical assessment and quality review of Individual case safety reports (ICSR), including submission to regulatory authorities as needed; Compliance monitoring and tracking; Reconciliation; Literature review, and occasional case processing as needed. Contributes to drafting and review of aggregate reports and Risk Management plans on products developed and manufactured by Apotex, in compliance with global drug safety regulations and ICH Guidelines. Interacts with health professionals and consumers and affiliate offices during investigation of all case reports. When required, participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities relating to Risk Management programs as required.

Job Responsibilities

•    Lead a team of approx. 15 associates of aggregate report writing function and will be responsible for manage project transitions, delivery and drive results in line with project KRAs
•    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.
•    Conducts literature reviews and provides assessment and analysis of published literature. 
•    Maintains current awareness of safety issues on Apotex products through ongoing monitoring & literature review demonstrating scientific skills in the research, analysis and interpretation of safety data.
•    Assists in the preparation/review of Risk Management plans. 
•    Informs management of trends.
•    Develops and maintains SOPs.
•    Develops and maintains training documents and tracks compliance of internal and external global partners involved in drug safety reporting. 
•    Prepares responses to slightly more complex queries, and requests for safety information from internal customer (RA, QA, NPD project teams etc.).
•    Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology.
•    Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities;
•    Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
•    Works as a member of a team to achieve all outcomes;
•    Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
•    Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion; and
•    All other duties as assigned.
•    May provide input and feedback to departmental process improvement strategy discussions.
•    Contributes to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data. 
•    Liaises regularly and develops strong working relationship with external partners and international Apotex affiliates and demonstrates corporate values in the performance of work and in all interactions with others.
•    Interacts with other internal departments when necessary.
•    Contributes to interpretation of PV regulations and applies sound decisions related to regulatory guidelines and policies.
•    Shows initiative to remain current on new PV regulations and international guidelines and seeks guidance from Group Leader and management to enhance knowledge.
•    Performs all work in accordance with all established ICH guidelines, regulatory compliance and safety requirements and maintains current knowledge on all relevant Pharmacovigilance regulations.
 

Job Requirements

•    Qualifications: MBBS with 4 to 7 yrs experience in a PSRM, signal detection, risk management role.
•    Prefer past experience to lead a 15 plus team successfully for at least of 4-5 years
•    Knowledge of GxP compliance in GPV with an exposure to have handled audits and inspections
•    Preferred experience as aggregate and/or medical writing, review and compilation to submission of at least 7-10 years 
•    Should be able to problem solve, provide technical expertise on medical writing like a subject matter expert and use best practices from industry to bring in innovative solutions as part of continuous improvement 
 

 

 

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.