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. 1.0202020202Responsibilities related to aggregate reports for scheduling, quality and compliance. ·02020202020202Responsible 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. ·02020202020202Responsible for managing Development Safety Update Reports (DSUR) related activities in collaboration with clinical safety team. 2.0202020202Responsibilities related to Risk Management Plan: ·02020202020202Providing safety input ·02020202020202Authoring and Reviewing RMPs 3.0202020202Responsibilities related to Signal Management ·02020202020202Provides assistance in the signaling process ·02020202020202Authoring signal reports ·02020202020202Conducting 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. 1.0202020202Study 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. 2.0202020202Ensure effective safety monitoring of ongoing clinical trials 3.0202020202Ensure effective safety collaboration with Viatris' co-development partners by establishing SDEAs, Joint PV meetings 4.0202020202Review study specific safety plans in liaison with PV operations team, Clinical development departments and concerned CROs 5.0202020202To represent company from clinical safety perspective in Data Safety Monitoring Board meetings 6.0202020202To act as clinical safety lead for Viatris' clinical development programs. 7.0202020202Training of internal teams, Local product safety or another departments regarding clinical safety 8.0202020202To represent PSRM in internal & external meetings02related to clinical safety and train Investigators involved in a particular clinical trial with respect to clinical safety aspects of the trial 9.02020202In liaison with Global Clinical; prepare, review and provide input into clinical trial applications.02Assisting in preparation of responses to health authority’s queries raised for a development programme 10.0202Active participation in clinical department team meetings concerning the conduct of the project and a particular trial. 11.0202Support Medical and Scientific Department in terms of reviewing and responding to medical and scientific enquiries related to Viatris products 12.0202Support internal teams in preparation of clinical safety documents eg DSURs, SAE case processing, SDEAs etc 13.0202Participate in signaling activities as required. 14.0202Train and develop a team of scientists for clinical safety 15.0202Global 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.
