Pharmacovigilance Professionals Wanted: Mumbai Apotex Inc Job Vacancies
Apotex Inc. is a Canada-based pharmaceutical company recognized for producing high-quality, affordable medicines accessible in over 75 countries. With a robust focus on drug safety, Apotex offers career opportunities for professionals passionate about ensuring global health compliance.Pharmacovigilance Executive Recruitment Notification
Job Title:
Executive, GBS-GPV-PSRMLocation:
Mumbai, Maharashtra, 400079Experience:
2–3 years in core pharmacovigilance activities.Educational Qualification:
- Physicians, Pharm.D, M.Pharm, or related health science disciplines.
Job Summary
As a Pharmacovigilance Executive at Apotex Inc., you will:- Prepare Periodic Safety Update Reports (PSURs/PBRERs/PADERs) for regulatory submissions.
- Conduct ongoing safety monitoring and literature reviews for Apotex products.
- Respond to safety-related queries from internal stakeholders like Regulatory Affairs (RA) and Quality Assurance (QA).
Key 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.
- 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.
- 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.
Application Process
Ready to take the next step in your pharmacovigilance career? Apply today and join a company dedicated to fostering innovation and excellence in global healthcare.👉 Apply Here
https://pharmastuff.org.in/job/pharmacovigilance-professionals-wanted-mumbai-apotex-inc