Pharmacovigilance Associate Job at Alvotech | Apply Now
The Alvotech Pharmacovigilance Job offers aspiring biopharmaceutical professionals an opportunity to join the Global Safety Data Management team as a Pharmacovigilance Associate. This role focuses on clinical safety and post-marketing pharmacovigilance activities, offering an opportunity to contribute to significant projects in the industry.
About The Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on the development and manufacturing of high-quality biosimilar medicines. Within the Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies and support post-marketing authorization related activities.
- Job Title: Pharmacovigilance Associate
- Location: Bengaluru
Alvotech Pharmacovigilance Job Description
In this Alvotech Pharmacovigilance Job, the Pharmacovigilance Associate will be responsible for all assigned Clinical Safety and post-marketing pharmacovigilance activities. This role involves working on safety data management activities for company clinical trials and post-marketing programs, while ensuring regulatory compliance and adherence to company processes.
Key Responsibilities
- Work on assigned Clinical Safety and post-marketing PV tasks (e.g. ICSR/SAE management, Regulatory submissions, Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD, etc.)
- Involved in Safety systems setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.)
- Maintain and optimize Global Pharmacovigilance processes ensuring compliance with international law and regulations (e.g. FDA, EMA, ICH).
- Collaborate cross-functionally with other PV department teams and other teams (e.g. Benefit-Risk management, Clinical trials, and Partner Compliance) to ensure on-time delivery and compliance.
- Work with other teams and departments in the company (e.g. Quality, Regulatory, IT, CPD, etc.) and externally with PV service providers and business partners.
- Deliver training on pharmacovigilance processes and standards to company staff and external parties.
- Participate in audits and inspections related to Safety Data Management activities.
Eligibility Criteria
- Education: Master’s Degree in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences.
- Experience: 2+ years in Pharmacovigilance/Drug Safety working in Safety data management functions with demonstrable hands-on experience in clinical trial safety and post-marketing PV activities.
- Expertise: Experience working in Safety systems (e.g., Argus, ARISg); previous experience with Veeva Safety Vault is a great advantage.
- Proven track record: Working with global products and clinical trials.
- Advantage: Previous experience with biologic and combination products.
- Knowledge: Detailed knowledge of PV processes, directives, regulations, and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.).
- Skills: Mature self-organization, time-management, and interpersonal skills.
- Communication: Excellent communication skills, maintaining a positive, result-oriented work environment.
- Independence: Ability to work independently, plan, organize, and deliver, feeling comfortable in a multicultural team.
- Willingness: Willingness to travel internationally, as required.
The opportunity at Alvotech for the Pharmacovigilance Associate position presents a significant chance for qualified candidates to engage in impactful work within the biopharmaceutical sector. Candidates interested in the Alvotech Pharmacovigilance Job are encouraged to apply at the earliest to be considered for this role.
