Pharmacovigilance Specialist

• JOB PURPOSE


• Ensure that Greater Gulf PV activities are performed in compliance with the GPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in the assigned country


• Establish and maintain a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training.


• Replaces the Saudi -QPPV in most of his/her tasks when he/she is out of the office, including acting as local PV contact for the authorities and being accountable for PV inspections

Job Description
* Serve as the L-QPPV back-up for the products of all Sanofi entities
* Replace the -QPPV in a sub-set of his/her tasks when he/she is out of the office, including acting as the back-up local PV contact for the authorities and for PV inspections/audits and will be supported by a CSH from the same Multi-Country Organization (MCO).
* Ensure that local PV activities are performed in compliance with the GPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in the assigned country.
* Monitors continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to GPV/Global PV entities and external stakeholders such as HAs, partners
* Supports the PV requirements for local activities around local programs (e.g. Patient Support Program, Market Research, Managed Access Program...) and company sponsored digital media
* Ensures local periodic reports are timely submitted, including PSRs and periodic reviews.
* Is aware of and strictly follows the local business continuity plan and after hours' emergency calls process
* Follows the process as per the global/local SDEA in place in case of global/local agreements with pharmaceutical companies (license-in, license-out, co-marketing-co-promotion, divestment….).
* Supports the Global Safety Officers (GSO) in local safety surveillance activities.
* Handles/escalates product safety alerts in a timely manner.
* Supports risk management activities and/or additional risk minimization measures implementation in Saudi Arabia in coordination with other relevant stakeholders.
* Performs assigned trainings pertaining to PV Liaison role in a timely manner.
Maintain Compliance
Abide by the requirements of the internal Code of Ethics including but not
restricted to maintaining high professional standards of conduct in line with
the Company procedure with a duty of care to the reputation of the Company
Ethical Leadership
* Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.
* Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role
Health, Safety and Environment Responsibilities
To care for his/her own safety and wellbeing and the safety of others, and to
co-operate with the company to ensure a safe place of work. Employees are
therefore expected to:
* Support and conform to Company HSE rules and procedures to ensure a safe, healthy, and pollution free work environment.
* Follow HSE guidelines and take all necessary measures applicable to effectively implement the 'HSE action plan (PASS)' in the work area and the activities.
* Follow the HSE rules and 'Act responsibly' to protect yourself and others from an injury and ill health conditions while at the work locations and/or while using road e.g traffic rules, emergency evacuation procedure, medical surveillance, healthy lifestyle, no smoking inside the office premises etc.
* Attend HSE training and implement the learnings.
* Participate in the HSE related activities, campaigns, events etc. and adopt the learning in day-to-day work activities.
* Report all the accident/ incident (if any) to the Line Manager and the HSE Manager and help to investigate further.
* Thoroughly read all HSE instructions, procedures, policies issued by the Company, and comply with its requirements. Escalate any doubts or uncertainties to the Line Manager.

KEY WORKING RELATIONSHIPS
INTERNAL
Cross Functional Collaboration with:
* Quality Unit
* Regulatory Unit
* Medical Unit
Occasional Contact with:
* Business Unit
EXTERNAL
Would be expected to be involved with:
* Regulatory Authorities
* Services Providers

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
* Education Level
* Experience
* Skills

PLAY TO WIN BEHAVIOUR
* Stretch
* Take Action
* Act for Patients and Customers
* Think Sanofi First
At Sanofi diversity and inclusion is foundational to how we operate and
embedded in our Core Values. We recognize to truly tap into the richness
diversity brings we must lead with inclusion and have a workplace where those
differences can thrive and be leveraged to empower the lives of our
colleagues, patients and customers. We respect and celebrate the diversity of
our people, their backgrounds and experiences and provide equal opportunity
for all.