Country Safety Head Indonesia
- Location: Jakarta, Indonesia_
- Full-time, permanent_
About Us:
At Sanofi Consumer Healthcare, we have one shared mission - we work passionately, every day, to 'serve healthier, fuller lives' now and for the generations to come. In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both a social and environmental point of view.
As one of Australia's largest vitamin makers and distributors, we are proud that our team is at the forefront of high quality in-house manufacturing and innovative new product development.
Everything we do is centered around people's interests - our consumers, our customers, healthcare professionals, and our employees - across the world.
We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu and with a large portfolio of vitamin, mineral, supplement, over the counter and personal care brands including Telfast, Mersynofen, Betadine, Bisolvon, Dulcolax, Nature's Own, Cenovis, Ostelin and many more.
We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.
The Position:
The Country Safety Head is a newly created role that will be responsible for the Pharmacovigilance (PV) of Indonesia, serving as the main point of contact and key leader for all PV related activities for Sanofi Consumer Healthcare products.
Role Responsibilities:
- Serves as the local PV contact for the authorities, is accountable for PV inspections and is nominated as local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations- Responsible for all activities, including but not limited to, case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs and market research programs for PV aspects- Ensures that local PV activities in the assigned country are performed in compliance with the Global policies, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country- Establish and maintain robust and efficient local PV systems in the designated country by ensuring the availability and implementation of proper systems/procedures tools and training. Support the QPPV in overseeing the PV activities in the country- Support with local budget planning and management- Build close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager.- Act as Deputy CSH for a partner country when applicable and assign own replacement when needed- Organisation and Maintenance of local PV Quality systems, and Operating & Safety Management Systems
- from compliance, local quality documents to be reviewed and appropriate, monitoring data and escalating product safety issues and alerts in timely manner to global- Periodic and Safety reporting, risk management and monitoring communications and audits- Reviewing relevant safety sections of local documents and contracts owned by other affiliates entities, such as labeling, contracts with third parties and local study protocols- Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests- In case of local PV outsourcing activities, collaborate with Global PV to implement the best outsourced capabilities- Collaborate with affiliate teams on best practices across designated region and globally- Act as the balance between local and global stakeholders and communicate strategies to encourage alignment on business objectives.
Key working relationships:
- PV Zone Head- Regional PV Head- Country Medical/Regulatory/Quality Teams and Country Manager- QPPV- Global PV Operations Team- Global Medical Safety Team- Network of PV Zone Heads and CSHs
About You & Key Criteria for the role:
Education & Qualifications:
- PHD/ MPh or Masters Degree in Life Sciences or Medical/ Clinical Medicine OR- Registered Pharmacist (locally verified), Pharm D
Experience and knowledge:
- 3+ years of Pharmacovigilance/ Clinical development experience in local country- Ideal background in Consumer Healthcare industry or Global CRO companies- Experienced with Regulatory Agency interactions- Knowledge of national PV regulations and international regulations regarding safety requirements as well as industry standards
**Skills**:
- Good written and verbal communication skills and good level of speaking/writing English- Strategic thinking mindset, always pushing to challenge the status quo and problem solving- Proactive in an autonomous role, leadership