- Medical Review of safety data for purpose of expedited/ periodic reporting for client’s products including MedDRA coding, labelling and causality assessment as well as conducting regular safety surveillance activities.
- Leading activities including conducting authoring of Pharmacovigilance reports including PBRERs, DSURs, Safety Evaluation Reports, cumulative reviews, input into Risk Management Plans, and Signal Detection of the ADRs with cases received for clients' products, ensuring assigned sections are accurate meeting client expectations of quality and timeliness.
- Providing responses to Health Authorities and/or supporting other team members with internal requests.
- Maintain awareness of changes to new regulations affecting Pharmacovigilance activities.
- Active participation in regulatory inspections and client audits.
- Responsible for oversight of all the activities related to Pharmacovigilance daily operations as well as liaising effectively and maintaining excellent relationship with clients and external contacts.
- Responsible for process implementation and ensure process compliance whilst managing project deliverables in line with the project plan.
- Develop and maintain quality control processes as well as undertaking QC tasks performed by other team members on an ongoing basis
- Act as a subject matter expert supporting the team through training and mentoring.
- Create error-free reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.
- Identifies and provides standards for gathering information for use in trend analysis and reports information to company management.
- Responsible for the performance management of the team on an ongoing basis. This may include regular interaction with team members, identify the areas of improvement and implement a subsequent training or mentoring plan to ensure all the team members meet or exceed targets with highest level of employee satisfaction.
- Responsible for creating or updating the SOPs, WINs as per project specific requirements.
- A minimum of a MBBS/MD
- A minimum of 2+ years of relevant Pharmacovigilance industry experience within a pharmaceutical company or a CRO
- Experience of authoring Pharmacovigilance aggregate reports and working knowledge of signal management.
- Project management including managing writing teams in Pharmacovigilance domain would be preferential
- Excellent written and verbal communication skills, including presentation to cross-functional teams
- Strong MS Word/ PowerPoint/ Excel knowledge
- Ability to manage time by planning and prioritising deliverables.
- Analytical capabilities, proficiency and comfort with the analysis of complex scientific data set.
- Commitment to highest quality outputs, including obsessive attention to detail
- Ability to be a successful team collaborator, but also self-motivated and able to work independently
- Knowledge of applicable global and regional regulatory requirements