Main responsibilities:
Replaces the CSH 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.
Supports the CSH in ensuring that local PV activities are performed in compliance with the PSPV 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(ies)
Supports the CSH in ensuring establishment and maintenance of a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training
OPTION: Operates as Local Safety Officer (LSO) by managing medical safety of assigned local products under the oversight of the Regions Medical Safety Head
OPTION: acts as Local Safety Officer (LSO) back-up and as such manage, in absence of LSO, the medical safety of assigned GPV local products with under the supervision of the Regions Medical Safety Head (RMSH).
OPTION: Serves as the local PV contact for the local authorities and acts as the local Responsible Person for Pharmacovigilance (RPP) where applicable per country legislation (this role can be delegated as needed)
Experience:
Experience with pharmacovigilance systems and safety-related product management in both clinical development and marketed products is highly recommended
A minimum of experience in either pharmacovigilance or regulatory or quality or medical or clinical development is necessary
Experience on required standards for high quality safety relevant documents, e.g. RMP, PBRER is a plus
Experience with Regulatory Agency interactions
Soft skills:
Leadership, able to create networks and to collaborate in an international cross-functional environment
Interpersonal skills of diplomacy and team player dynamics; knowledge of and respect for cultural differences; professionalism and mediation are important
Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure
Ability to work in international and transversal teams.
Technical skills:
Robust knowledge of pharmacovigilance systems & regulations
Sufficient ability to interpret clinical data including safety data
Able to evaluate & manage safety signals and define risk management activities
Education:
Advanced health care discipline degree (M.Pharmacy, B.Pharmacy or MBBS.) or equivalent qualification with 5 Years Experience.
Languages:
Professional English language proficiency
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kochi | Malappuram |Madhya Pradesh :
Indore |Maharashtra :
Amravati | Aurangabad | Kolhapur | Mumbai | Nagpur | Navi Mumbai | Pune | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata |Arizona :
Chandler | Tempe | Tucson |California :
Davis | Emeryville | Foster City | La Jolla | Los Angeles | Pasadena | Riverside | San Diego | San Francisco | San Gabriel | Santa Clara | Santa Monica | Stanford |Colorado :
Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Tallahassee |Georgia :
Atlanta |Illinois :
Abbott Park | Champaign | Chicago | Deerfield |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |Maryland :
Baltimore | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Linden | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Warren Grove | Westfield | Whippany |New York :
Buffalo | Ithaca | Morningside Heights |North Caroline :
Chapel Hills | Durham | Morrisville | Raleigh |Ohio :
Columbus, |Pennsylvania :
Philadelphia | Pittsburgh |Tennessee :
Nashville |Texas :
Austin | Houston |Virginia :
Blacksburg |Washington :
Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |New South Wales :
Sydney |Queensland :
Queensland |United Kingdom :
London |Serbia :
Belgrade |Republic of Ireland :
Limerick | Dublin |Remote :
Switzerland | Remote | Remote, USA | Remote - Europe |Makkah :
Najran | Jeddah |