Local Medical Safety Specialist
6 months contract, Cover Maternity Leave
Come and join us!
Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?
“FIND YOUR PLACE” by joining a world-class US Consumer company
Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.
Company Description:
Our client is an American consumer health company. It is the proprietor of well-known consumer brands. They combine the power of science with meaningful human insights to empower people around the world to live healthier lives.
Summary
We have a new and exciting opportunity to hire a Local Medical Safety Specialist. The Local Medical Safety Specialist will be responsible for managing local safety activities for medicinal products in compliance with local regulations and company policies. This role requires strong knowledge of pharmacovigilance and the ability to ensure proactive benefit-risk management throughout the product lifecycle.
The Local Medical Safety Specialist will report to the Cluster Safety Lead (CSL) Singapore & Philippines, within the International Pharmacovigilance (IPV) organization.
Principle responsibilities:
The responsibilities include, but not limited to:
- Work closely with the CSL (Cluster Safety Lead) to ensure that the Local Operating Company (LOC) safety activities, related to medicinal products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any Pharmacovigilance (PV) agreements with third party business partners.
- Accountable for activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
- Establish adequate collaboration with local and regional team to maintain local compliance oversight for day-to-day Individual Case Safety Reports (ICSRs) management including HA correspondence, regulatory intelligence etc.
- Maintain oversight of data generating activities, e.g., patient support programs (PSPs), market research activities, etc. and provide safety inputs into protocols and agreements to ensure appropriate review and inclusion of safety reporting process.
- Manage Local Medical Safety activities to ensure the pro-active benefit-risk management throughout product life cycle and translate global safety data to insights and actions tailoring to local specificities and needs.
- Establish product knowledge with focus on safety profiles, therapeutic area, and disease pathway knowledge in supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader.
- Participate in cross-functional team meetings and act as safety expert for discussion and evaluation of topics related to benefit-risk and product safety.
- Ensure Risk Management Plan (RMP) implementation at country level, prepare local RMPs/addendum and be involved in local safety signal detection, as applicable.
- Take appropriate measures and collaborate with cross-functional team to ensure new safety information is made available to HA and Healthcare Professionals (HCPs) in a timely manner.
- Ensure implementation of all PV relevant procedural documents and verify adherence. Where appropriate, develop local controlled procedures to cover local aspects of PV activities.
- Maintain training plan for local PV personnel and awareness of safety reporting in general for LOC employees, distributors/vendors by providing training and maintain proper documentation.
- Maintain oversight on safety policy and strategy, including monitoring, implementing PV regulations, and shaping regulatory environment.
- Act as the local PV contact person for all internal and external PV audits and inspections, and address follow-up actions from findings to ensure responses/corrective actions are tracked and completed timely.
Qualifications, Experience, Knowledge, and Skills
- Bachelor’s degree in the Medical, Pharmacy, Life Sciences, or related scientific field (or equivalent experience) is required.
- Minimum 3 years of experience within the pharmaceutical industry on pharmacovigilance is preferred. An equivalent year of working experience within healthcare environment will be considered.
- Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.
- Proven ability to coordinate workflow activities and prioritize multiple critical issues.
- Computer literate with basic knowledge of safety database systems.
EA License: 94C3609
Reg No: R1440247
