Company: Apotex Inc.
Location: Mumbai, India
Industry: Pharma/ Healthcare/ Clinical Research
Functional Area: Pharmacovigilance PV PSRM
Job Type: Full-time
Experience: 2-3 years
Qualification: Pharm.D, M.Pharm
End Date: 30th July 2024
Primary Responsibilities:
- Prepare periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
- Maintain current awareness of safety issues on Apotex products through ongoing monitoring and literature review.
- Prepare responses to queries and requests for safety information from internal customers (RA, QA, NPD project teams).
- Ensure adherence to all compliance programs including Global Business Ethics, Global Quality policies, Safety and Environment policies, and HR policies.
Additional Responsibilities:
- Develop and maintain SOPs and training documents.
- Track compliance of internal and external global partners involved in drug safety reporting.
- Maintain user-level knowledge of Oracle ARGUS and MedDRA terminology.
- Work as part of a team to achieve outcomes and support the Values of Collaboration, Courage, Perseverance, and Passion.
- Perform other duties as assigned.
Supporting Responsibilities:
- Provide input and feedback to departmental process improvement strategy discussions.
- Contribute to creating a teamwork environment ensuring excellence in customer service through the timely delivery of quality drug safety data.
- Develop strong working relationships with external partners and international Apotex affiliates.
- Interact with other internal departments as necessary.
- Contribute to interpreting PV regulations and applying sound decisions related to regulatory guidelines and policies.
- Show initiative to remain current on new PV regulations and international guidelines and seek guidance to enhance knowledge.
- Perform all work in accordance with established ICH guidelines, regulatory compliance, and safety requirements.
Candidate Profile:
- Physicians, Pharm.D, M.Pharm, Nursing, or related Health Science discipline.
- Excellent analytical and problem-solving skills.
- Excellent oral and written communication skills in English.
- Knowledge of MedDRA, Oracle ARGUS, and online literature searching preferred.
- Excellent organizational and interpersonal skills; experience 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.
- Core PV experience of at least 2-3 years’ pharmaceutical experience.
- Preferred experience of at least 1-2 years on periodic reviews on aggregate safety data.
Additional Information: Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients worldwide. Apotex employs almost 8,000 people in manufacturing, R&D, and commercial operations, and operates in more than 45 countries.
Application Deadline: 30th July 2024
To apply, please visit our career page or contact our HR department.
