Medical Information and Promotional Compliance officer

Salary
On Application
Posted
04 Dec 2018
Closes
10 Jan 2019
Ref
TD10005
Contract Type
Permanent

My client, a global pharmaceutical company now have a new opportunity for a Medical Information and Promotional Compliance officer.   Based in Dublin your role will be to perform Medical Information and promotional compliance monitoring activities for the Company group products


Key responsibilities:
Medical Information
•    Receive and Manage Medicinal Product Complaint Reports submitted by the affiliates, Distributors and Medical Information Service providers adhering with company Standard Operating Procedures (SOP’s);
•    Ensure that adequate support is provided in a timely manner to Medical Information service providers/distributors/ affiliates/complainant in responding to medical information enquiries;
•    Ensure information and reviews obtained are reverted to Complainant/Affiliate/Distributor/Medical Information service provider within the agreed timelines per affiliate;
•    Ensure that relevant metrics report received from Medical Information service provider/distributor/affiliate is reviewed and provide regular feedback.
•    Ensure that Affiliate/Distributor/Medical Information service provider is adhering with company’s policy in providing scientific support to internal and external customers;
•    Identify gaps and suggest ways of process improvement in Internal Medical Information service and Medical Information service provided by Affiliate/Distributor/Medical Information service provider;
•    Ensure that relevant department is communicated in a timely manner following the receipt of Adverse Event or product quality complaint in Medical Information function;
•    Ensure that the reconciliation between Medical Information function and Pharmacovigilance and Quality department is effective by performing ad-hoc review on reconciliation files;
•    Ensure that Recall SOP, is followed as per policies and procedures
•    Advise affiliates regarding Pharmacovigilance, Medicine Information and Product Labelling requirements of current approved and new product licenses;
•    Determine requirements for change control of Medicinal product Labels, PIL’s and SPC’s in a medical information perspective from each territory when requested;
•    Liaise with Quality and Regulatory to understand the status of products and feedback to QPPV or equivalent in the affiliates;
•    Liaise with distributors and provide feedback to line manager;
•    Support in centralising the Medical Information function for the Group.
•    Support in Implementation and Validation of Medical Information database globally;
•    Ensure that the medical information database implemented in maintained Information System globally;
•    Support in training distributors on how to interact with the company as specified in Safety Data Exchange Agreement;
•    Ensure external websites for Summary of product characteristics and Patient Information Leaflet are maintained up to date and ensure ad-hoc Quality check is performed to ensure the correctness of the file present in the website;
Promotional compliance monitoring
•    Ensure all promotional material and compliance monitoring activities adhere to company policies and processes 
•    Ensure compliance monitoring is performed on all territories and escalate noncompliance in a timely manner to line manager as per group policies
•    Ensure support and training is delivered to local team, where necessary
•    Copy approval and review of educational and promotional materials through Zinc or other identified platform as per policies and procedures; where requested

•    Qualifications & Experience
Bachelors or Post Graduate degree in science, pharmacy or medicine; Facilitator training will be an advantage;
•    Working with remote team is considered as an advantage;
•    Minimum 3 to 5 years’ experience in Medicine Information Unit;
•    Effective use of appropriate IT systems and programs. 

For full job spec and details contact Tina by emailing tdunne@thornshaw.com or call +353 1 2784701

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