Share Service Center Patient Safety Associate
A new position has opened up in our Patient Safety Department and the role will be based in our Riyadh Office.
We are looking for a PV Associate and a Qualified Person for Pharmacovigilance (QPPV). This is an excellent opportunity to advance and learn in a leading innovative pharmaceutical company. You will be accountable for performing Pharmacovigilance (PV) tasks under the supervision of the SSC Manager Middle East.
What You Will Do
You will perform in full compliance with all relevant global and local regulatory requirements and company standards and these tasks include, but not limited to:
- Continuous process improvements in the field of safety surveillance, including the handling of local drug safety information, collection, processing, translation from local language into English, and transmission to Global Patient Safety (GPS) as applicable in a timely manner.
- Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner.
- Performing screening of relevant local medical/scientific literature in accordance with GPS procedures and local requirements (where applicable) and keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling.
- Performing screening of relevant local health authority website(s) according to global standards and as defined by relevant internal quality documents (where applicable).
- Reporting to local Health Authorities and Ethics Committees (where applicable), which includes timely submission of expedited ICSRs and any other safety related issue to concerned local competent authority(ies).
- Working closely with the SSC Manager Middle East and contributing to the Local Pharmacovigilance file(s) creation and/or updates to ensure completeness, accuracy and that relevant information is captured and updated in a timely manner.
- Tracking of clinical development and Patient Data Collection Systems (PDCS) activities in the assigned countries and supporting the SSC Manager Middle East in having a complete overview on relevant local/regional clinical studies and PDCS (ongoing and planned) in the local affiliates assigned to you.
- Training activities such as completion of all mandatory PV trainings in a timely manner, Supporting PV training activities under the supervision of the SSC Manager Middle East and supporting the SSC Manager in PV related trainings as required.
- Collaborating cross-functionally and cross-regionally to ensure local PV requirements are met and integrated into relevant procedures.
Required Skills and Abilities
- Fresh graduate or with maximum 1-year experience in Pharmacovigilance in pharmaceutical industry or health authority.
- Pharmacy graduate, resident in Riyadh Saudi Arabia (office location: Riyadh).
- Fluent in written and spoken Arabic and English.
- Effective presentation skills with Microsoft office proficiency.
- Able to keep meticulous records, demonstrate attention to details.
- Able to demonstrate problem-solving skills with a systematic approach to tasks and demonstrate decision-making ability.
- Can interact and demonstrate strong intercultural skills and can communicate effectively with a wide range of people.
- Willing to work within a team and show strong teamwork skills.
- Can work across cultural and functional boundaries participating in virtual teams.
- Can prioritize work and adapt rapidly to changing priorities.
- Able to manage multiple situations/issues under time pressure.
- Traveling domestically and internationally up to 10% of your time.