Summary and Responsibilities：

Lead Safety Surveillance and Risk Management

To assist in the global pharmacovigilance activities within global PSRM for Viatris in accordance with Company, international standards and regulatory requirements, as assigned.

1. Responsibilities related to aggregate reports for scheduling, quality and compliance.

· Responsible for managing Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO) related activities (including but not limited to PSUR scheduling, data collection, writing, review, handling of requests received from Central & Local Regulatory Affairs and PV departments) within respect of timelines and any other related task.

· Responsible for managing Development Safety Update Reports (DSUR) related activities in collaboration with clinical safety team.

2. Responsibilities related to Risk Management Plan:

· Providing safety input

· Authoring and Reviewing RMPs

3. Responsibilities related to Signal Management

· Provides assistance in the signaling process

· Authoring signal reports

· Conducting safety reviews

Lead Clinical Safety

Ensure patient safety for all Viatris products in Clinical Development by continuously improving and aligning procedures and striving for Operational Excellence. Ensure compliance to local, regional and global regulation and legislation.

1. Study Specific Safety document review and approval: timely review of Protocols, IBs, Clinical study reports for scientific and safety aspects originating from Viatris clinical development program.

2. Ensure effective safety monitoring of ongoing clinical trials

3. Ensure effective safety collaboration with Viatris' co-development partners by establishing SDEAs, Joint PV meetings

4. Review study specific safety plans in liaison with PV operations team, Clinical development departments and concerned CROs

5. To represent company from clinical safety perspective in Data Safety Monitoring Board meetings

6. To act as clinical safety lead for Viatris' clinical development programs.

7. Training of internal teams, Local product safety or another departments regarding clinical safety

8. To represent PSRM in internal & external meetings related to clinical safety and train Investigators involved in a particular clinical trial with respect to clinical safety aspects of the trial

9. In liaison with Global Clinical; prepare, review and provide input into clinical trial applications. Assisting in preparation of responses to health authority’s queries raised for a development programme

10. Active participation in clinical department team meetings concerning the conduct of the project and a particular trial.

11. Support Medical and Scientific Department in terms of reviewing and responding to medical and scientific enquiries related to Viatris products

12. Support internal teams in preparation of clinical safety documents eg DSURs, SAE case processing, SDEAs etc

13. Participate in signaling activities as required.

14. Train and develop a team of scientists for clinical safety

15. Global SOP preparation and review

Qualifications:

• Medical Graduate or post graduate / health sciences.
• At least 5 - 8 years pharmaceutical industry experience working within pharmacovigilance.
• Excellent time management skills and must be able to work to tight timelines.
• Ability to manage own workload and interact well in a team environment.