Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 1K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

WINNERS AWAITED!
- ABECA 2025
  
  WINNERS AWAITED!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

Add office photos

Engaged Employer

Apotex Research

Compare

4.1

based on 766 Reviews

3 Apotex Research Senior Analyst Jobs

Senior Analyst, GBS-GPV PSRM-GBS-PSRM G

APOTEX PHARMACHEM INDIA PRIVATE LIMITED

4.1

based on 766 Reviews

1-2 years

₹ 3 - 6.25L/yr (AmbitionBox estimate)

Mumbai

1 vacancy

Senior Analyst, GBS-GPV PSRM-GBS-PSRM G

Apotex Research

posted 1mon ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Customer Service Pharmacovigilance Oracle Clinical Data Management Analytical Chemistry

+ 4 more

Job Description

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com .

Job Summary

Prepares periodic safety update reports (PSURs/ PBRERs) in compliance with drug safety regulations and ICH Guideline. Utilizes best medical judgement in the analysis and evaluation of adverse reports, promptly resolving causality assessment queries and any other impreciseness in reporting by actively liaising with the reporting sites. Participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.

Job Responsibilities

Primary responsibilities

Prepares periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
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.

Prepares responses to slightly more complex queries, and requests for safety information from internal customer (RA, QA, NPD project teams etc.).
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.

Additional responsibilities

Develops and maintains SOPs.
Develops and maintains training documents and tracks compliance of internal and external global partners involved in drug safety reporting.
Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology.
Works as a member of a team to achieve all outcomes.
Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion.
All other duties as assigned.

Supporting responsibilities

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

Education
- B Pharm, Pharm.D, M Pharm, Nursing or related Health Science discipline
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
Experience

Core PV experience of at least 1-2 years pharmaceutical experience
Periodic safety and risk management scientist: Preferred experience of at least 1-2 years on periodic reviews on aggregate safety data

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.

Employment Type: Full Time, Permanent

Read full job description

Prepare for Senior Analyst roles with real interview advice