Lead Exec, GBS-GMA-GPV PSRM-GBS-PSRM G

Apotex Inc.; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Disability accommodation

Accessible environment

Job summary

Apotex Inc. in Mumbai, India, is seeking a Pharmacovigilance Scientist to prepare and review PSURs/PBRERs and support global NPD and PLCM activities. You will analyze safety data, liaise with sites, and ensure timely regulatory submissions in line with ICH guidelines.

The role requires 3–5 years in PV, strong English communication, and knowledge of MedDRA and Oracle ARGUS. Experience with global safety reporting and cross-functional teams is preferred, with a focus on quality and compliance.

Qualifications

• Physicians, Pharm.D, M Pharm, Nursing or related Health Science discipline required.
• 3–5 years core PV experience; 1–2 years on periodic safety reviews preferred.
• Excellent knowledge of local and international PV regulations and ICH guidelines.

Responsibilities

• Prepare and review PSURs/PBRERs/PADERs for regulatory submissions.
• Monitor safety issues through literature review and data interpretation.
• Respond to safety information requests from internal teams (RA, QA, NPD).
• Ensure compliance with Global Ethics, Quality, Safety, Environment, and HR policies.

Skills

Analytical skills

Problem-solving

English communication

Interpersonal skills

Regulatory knowledge

Education

Health science degree

Tools

MedDRA

Oracle ARGUS

Microsoft Office

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.

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

• Prepares and conducts peer review of 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
  • 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.