In the position as PV Operational Associate we are offering you an opportunity to play a key role in ensuring safe compliant and high-performing pharmacovigilance systems across our Regional PV Team. Youll join a dynamic work community supported by knowledgeable colleagues and continuous learning opportunities. Reporting to the PV Operational Team Lead this role is central to our commitment to patient safety and regulatory excellence.
This position is accountable for executing day-to-day PV operations and compliance activities to maintain robust pharmacovigilance systems primarily toward the Finnish affiliate as well as where required the Scandinavian affiliate. You will ensure regulatory and company standards are met supporting AbbVies dedication to quality and safety. The position is based in our Helsinki office.
Your responsibilities may include:
- Support the provision of PV system metrics maintaining oversight of all performance indicators for compliance with local regulations and AbbVies internal standards.
- Develop maintain and continuously improve local/regional quality management procedures in accordance with both corporate and country-specific requirements.
- Perform impact assessments for new or updated corporate policies/processes and support PV exception reporting CAPA management and business continuity plans/testing.
- Individual Case Safety Report (ICSR) activities: case recording follow-up literature review ongoing reconciliation and robust quality control.
- Assist with internal audits audits of affiliate service providers/partners and regulatory PV inspections. Support CAPA development and timely execution of corrective actions.
- Ensure all PV requirements are in place for activities with potential identification or handling of safety information always maintaining full compliance.
- Maintain PV training compliance and develop training materials overseeing a comprehensive PV Training Matrix.
- Monitor and assess the impact of local and regional PV legislation/intelligence ensuring processes are continuously updated.
Qualifications :
- Bachelors degree or higher in life sciences pharmacy medicine or a related field
- A minimum of 2 years experience required within the pharmacovigilance or a related field
- Effective communicator and able to work effectively in teams and a cross functional environment.
- Strong commitment to compliance with relevant rules and procedures.
- Effective planning and organizational skills and the ability to complete activities with high quality.
- Fluency in Finnish both written and spoken. Strong capability in English both written and spoken. Swedish language capability is a plus.
Additional Information :
Youll belong to a collaborative team passionate about patient safety quality and continuous improvement. We support your professional growth with access to learning resources and meaningful career development opportunities.
Interested candidates should submit a CV and cover letter outlining relevant experience and motivation for the position. Applications will close on the 5.12.25. We will review applications ongoing so please apply at your earliest convenience
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
In the position as PV Operational Associate we are offering you an opportunity to play a key role in ensuring safe compliant and high-performing pharmacovigilance systems across our Regional PV Team. Youll join a dynamic work community supported by knowledgeable colleagues and continuous learning op...
In the position as PV Operational Associate we are offering you an opportunity to play a key role in ensuring safe compliant and high-performing pharmacovigilance systems across our Regional PV Team. Youll join a dynamic work community supported by knowledgeable colleagues and continuous learning opportunities. Reporting to the PV Operational Team Lead this role is central to our commitment to patient safety and regulatory excellence.
This position is accountable for executing day-to-day PV operations and compliance activities to maintain robust pharmacovigilance systems primarily toward the Finnish affiliate as well as where required the Scandinavian affiliate. You will ensure regulatory and company standards are met supporting AbbVies dedication to quality and safety. The position is based in our Helsinki office.
Your responsibilities may include:
- Support the provision of PV system metrics maintaining oversight of all performance indicators for compliance with local regulations and AbbVies internal standards.
- Develop maintain and continuously improve local/regional quality management procedures in accordance with both corporate and country-specific requirements.
- Perform impact assessments for new or updated corporate policies/processes and support PV exception reporting CAPA management and business continuity plans/testing.
- Individual Case Safety Report (ICSR) activities: case recording follow-up literature review ongoing reconciliation and robust quality control.
- Assist with internal audits audits of affiliate service providers/partners and regulatory PV inspections. Support CAPA development and timely execution of corrective actions.
- Ensure all PV requirements are in place for activities with potential identification or handling of safety information always maintaining full compliance.
- Maintain PV training compliance and develop training materials overseeing a comprehensive PV Training Matrix.
- Monitor and assess the impact of local and regional PV legislation/intelligence ensuring processes are continuously updated.
Qualifications :
- Bachelors degree or higher in life sciences pharmacy medicine or a related field
- A minimum of 2 years experience required within the pharmacovigilance or a related field
- Effective communicator and able to work effectively in teams and a cross functional environment.
- Strong commitment to compliance with relevant rules and procedures.
- Effective planning and organizational skills and the ability to complete activities with high quality.
- Fluency in Finnish both written and spoken. Strong capability in English both written and spoken. Swedish language capability is a plus.
Additional Information :
Youll belong to a collaborative team passionate about patient safety quality and continuous improvement. We support your professional growth with access to learning resources and meaningful career development opportunities.
Interested candidates should submit a CV and cover letter outlining relevant experience and motivation for the position. Applications will close on the 5.12.25. We will review applications ongoing so please apply at your earliest convenience
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Work :
No
Employment Type :
Full-time
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