Lead Executive PSRM

Apotex Inc.; Mumbai; On-site; INR 900,000 - 1,400,000; Full time

Benefits offered by this job

Disability accommodation

Global exposure

Job summary

Apotex Inc. in Mumbai, India seeks a Pharmacovigilance scientist to prepare and review PSURs and PBRERs. The role involves evaluating adverse reports, conducting causality assessments, and liaising with global sites to ensure timely safety updates.

The successful candidate will monitor safety signals, review literature, maintain PV documentation, and support regulatory submissions in accordance with ICH guidelines and company policies. Strong analytical and communication skills are essential.

Qualifications

• Educated in Physicians, Pharm.D, M Pharm, Nursing or related Health Science discipline.
• Strong analytical and problem-solving abilities with pharmacovigilance focus.
• Proficient in MedDRA terminology and PV data handling.
• Experience with regulatory pharmacovigilance activities and ICH guidelines.

Responsibilities

• Prepares and reviews periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
• Maintains awareness of safety issues on Apotex products through literature review and data interpretation.
• Ensures compliance with Global Quality policies, Safety policies, and regulatory requirements.
• Develops SOPs and training materials related to drug safety reporting.

Skills

Analytical skills

English communication

MedDRA

Oracle ARGUS

Literature searching

Organizational skills

Team collaboration

Regulatory knowledge

Microsoft Office

Education

Pharmacy degree

Tools

Oracle ARGUS

Job description

Job Description:

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

Job Summary

Prepares/ reviews 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

• Preparesandconducts peerreview ofperiodicsafetyupdatereports(PSURs/PBRERs/PADERs) for regulatorysubmission.


• Maintains current awareness of safety issues onApotexproducts through ongoing monitoring & literature review demonstrating scientific skillsinthe 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

• Mayprovide input and feedbacktodepartmental 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 otherinternaldepartments 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
  
  
  • Physicians, 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 3-5 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 a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer 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.

Requirements: