Pharmacovigilance (PV)
Let's explore the responsibilities of this role.
Sound interesting?
Check out the Insiders Guide to Working in Life Sciences and the Secure a Job as a PV Associate course.
What Does a PV Associate Do?
The expectations from your Manager include areas such as an understanding of the risk management procedures and drug safety procedures of both the company and local regulatory authorities.
You will be required to:
- Maintain a high level of training and procedural guidance regarding the company- wide pharmacovigilance (PV) programs
- Contribute to the development and implementation of the safety and risk minimisation in all programs within the company
- Act as an expert/resource for internal and external stakeholders relating to drug safety
- Training and mentoring internal stakeholders within the relevant therapeutic areas
- Engaging in peer-to-peer level dialogue with key stakeholders, as drug safety reporting can come from any members of the community
- Establishing relationships with key stakeholders to educate and ensure awareness of PV activities within the company
- Providing internal stakeholders with information collected regarding product safety
- Identifying projects which had the potential to collect safety information and become involved in their set up and ongoing management
- You will also work with regulatory teams to write the product RMP (Risk Management Program) for products and manage its reporting
- Adherence to internal processes and external regulations including the relevant Code of Conduct and pharmacovigilance activities to meet internal SOP and local regulations is important.
