Pharmacovigilance Process Expert

Job Purpose: end to end management of Aggregate Report processes across company and leadership of PS&PV projects to ensure compliance to global regulatory requirements with maximum efficiency.

Responsibilities:

-Drive continuous process improvement by alignment of relevant stakeholders globally and locally, assessing opportunities for streamlining and automation.

-Lead assigned PS&PV projects and support higher complexity/criticality projects led by (Senior) Vigilance Process Managers, including IT projects/systems, in alignment with the company and department strategy.

-Collaborate closely with the product owner and product team, to ensure that the product meets the required standards and is fit for its intended purpose. This involves providing expertise in process management, identifying, and mitigating risks, ensuring compliance with relevant regulations, and facilitating continuous improvement.

-Act as process owner / deputy process owner for assigned vigilance processes.

-Develop, implement and perform monitoring activities designed to ensure safety cases processed in the safety database and aggregate safety reports produced meet the company's group standards and are produced and submitted according to company's internal and worldwide regulatory timelines.

-Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), contribute to the preparation of responses to findings and the development and implementation of corrective and preventative actions in alignment with the company strategy.

-Support collaboration with other Global Line Functions across company and Third Parties to establish and meet joint accountabilities.

-Support as business representative during mergers, spin-offs and acquisitions.

-Represent the company externally as a subject matter expert ad-hoc.

-PhD, PharmD, MSc degree or Life Sciences degree or equivalent.

-Fluency in English. Knowledge of other languages desirable.

-Minimum 2-4 years of experience in the pharmaceutical industry, particularly pharmacovigilance.

-Experience of leading working groups.

-Procedural document writing experience.

-Good analytical skills / proven ability to work with data.

-Strong presentation and communication skills, and ability to operate effectively in an international environment and across functions.

-Ability to mentor and coach.

A leading multinational pharmaceutical company is looking for a Pharmacovigilance Process Expert. This role is offered as a 6 month temporary contract.