Pharmacovigilance Manager

**We are growing, grow with us**
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

**Pharmacovigilance Manager**

**Your Job**
- Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection.
- Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO) and Clinical Expert Statements.
- Preparation of Risk Management Plans (RMPs), identify potential risks and provide advice with regard to future risk minimisation activities other than routine pharmacovigilance for the client product entire life cycle.
- Medical review and case management for all kind of reports, including PSURs, DSURs, RMPs. Reviewing the documents, checking for completeness and evaluating the report quality
- Preparation of responses to PRAC assessment reports and other Authority requests (e.g., referrals, etc).
- Publishing, distribution, archiving and submission of safety reports.
- Preparation of Signal detection reports, including EVDAS screening if applicable.
- Preparation of SARs (Signal Assessment Reports).
- Performing signal detection and signal analysis of safety data, provide the appropriate expert advice as well as assisting in communication with regulatory agencies when the new data has an effect on the risk-benefit balance.
- SOP services/writing and review of SOPs, WIs and related documents and training material in the area of pharmacovigilance for clients (including implementation and training.

**Management tasks**:

- Development of customer-specific solutions and processes in cooperation with clients.
- Build, develop and maintain working relationships with clients.
- Ensure client satisfaction and compliance with legal and regulatory requirements.
- Representation of the company and the team with clients, authorities and professional institutions.Inform the Head of the Pharmacovigilance Team regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to present solutions.
- Management of parts of a project or the complete project.
- Fulfilling highly complex, sophisticated tasks within the area of pharmacovigilance.
- Trigger a non-conformity when any performance deviation from the target KPI (Key Performance Indicator) is detected, issue evaluation and root cause analysis, assign corrective actions with a due date to the most appropriate employee, ensure that all agreed actions are completed by the due date.
- Communicate proactively with clients about the status of the project and provide solutions to address process deviations, quality issues and inefficiencies.
- Development of processes and/or tools within the area of pharmacovigilance in collaboration with the Head of the team and the Head of the Pharmacovigilance Department.
- Design and prepare Standard Operational Procedures, Working instructions and Client Specifications for Pharmacovigilance processes, ongoing revisions and implementation of updates.
- Client audits (preparation of the audit, defend it, review the audit report and follow action plan).

**Your Profile**
- Successful completion of a Bachelor’s degree in medical, natural sciences or pharmacy-related field, ideally also a PhD or Master degree.
- Professional experience in the field of pharmacovigilance.
- Knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance.
- Familiarity with industry principles of pharmacovigilance.
- Knowledge of pertinent medical or pharmaceutical and clinical practice.
- Detailed knowledge regarding project-related SOPs (internal and client-specific), global and local PharmaLex SOPs and pharmacovigilance related SOPs.
- Experience in the technical tasks that are performed by the members of the pharmacovigilance department.
- Self-confidence and assertiveness.
- Strategic, analytical and structured thinking.
- Experience in coordinating and planning activities, ideally experience in personnel management (e.g., effective coordination of personnel resources for time-conflicting projects).
- Experience in defining and implementing projects, strategies and processes.
- Good leadership skills and ability to motivate teams.
- Ability to assimilate and analyse information rapidly.
- Ability to identify and offer solutions to problems in a pragmatic way.
- Ability to represent the company with clients and externals.
- Ability to balance client concerns and company interest.
- Flexibility and adaptability to adjust rapidly to new, unknown, challenging situations.
- Fluent Spanish and English skills.
- Excellent written a