[J270] - Manager, Pharmacovigilance & Medical Information

[J270] - Manager, Pharmacovigilance & Medical Information

24 May
|
Knight Therapeutics.
|
Canada

24 May

Knight Therapeutics.

Canada

Work remote until further notice



Position Summary



Reporting to the Senior Director of Scientific Affairs, this full-time position will assume responsibilities within the Scientific Affairs department to ensure the maintenance of pharmacovigilance compliance of the pharmaceutical products in Canada, lead the medical information activities and support the scientific communication tools development. The manager will also support the implementation of a global Pharmacovigilance and Medical Information database. The manager works in collaboration with corporate partners and the other Knight departments. The manager is highly organised, has flexible and adaptable communication capabilities and demonstrates good problem solving skills.

This is a Montreal-based position.



Responsibilities



- The manager is responsible to lead and oversee the Pharmacovigilance (PV) / Medical information (MI) activities and ensure the activities are conducted in compliance with Health Canada requirements.

- Prepare and review all pharmacovigilance agreements.

- Prepare or review Annual Safety Reports and/or Risk Management Plans.

- Responsible for ensuring that all Knight employees are appropriately trained on adverse reactions reporting responsibilities upon on-boarding and a refresher training session is conducted on annual basis.

- Liaise efficiently with external pharmacovigilance counterparts and with pharmacovigilance/medical information external provider.

- Conduct Good Pharmacovigilance Practice (GVP) audits for partners and providers and also self-inspections, as per Applicable Regulations.

- Prepare the frequent asked questions (FAQs) and/or standard response letters (SRLs) for Knight’ products.

- Participate to the medical review of the product’s labelling.

- Address any scientific requests coming from the pharmaceutical representatives and/or Health Care Professionals.

- Support in the medical review and development of scientific communication and promotional tools.

- Develop the Medical Information, Pharmacovigilance and Scientific Communication working processes (e.g., Standard Operating Procedures (SOPs), Working Instructions (WI), Flow Charts).

- Collaborate with Knight’s Regulatory Affairs Department, review/prepare safety post-marketing changes to pharmaceutical

- Collaborate with Knight’s Quality Assurance, evaluate post-marketing changes to pharmaceutical

- Support the implementation of a Global Pharmacovigilance & Medical Information database.



Characteristics of a Good Candidate



- Analytical and Organisational Skills



- Teamwork / Negotiation skills



- Autonomy / Problem Solving



- Dealing with Ambiguity



Qualifications/Job Requirements



Required



- B.Sc. in life science discipline or equivalent

- Minimum of 3 years in Canadian Pharmacovigilance Affairs

- Good scientific knowledge

- Good communication skills, written and oral in English and French

- Good knowledge of Microsoft Office Suite



Asset



- Bachelor of Pharmacy (B. Pharm.) or Medicine (M.D.).

- Good knowledge of drug development, Canadian regulations and Good Pharmacovigilance Practices (GVP).





To apply, please send your CV to: [email protected]



Thank you for your interest. Only selected candidates will be contacted.





Why Knight?

Are you looking for a dynamic workplace where rapid decision making, entrepreneurial spirit and community are embedded in the DNA? Headquartered in Montreal, Canada, Knight Therapeutics is a fast-growing specialty pharmaceutical company focused on acquiring or licensing innovative pharmaceutical products for the Canadian and select international markets.

If you think you have what it takes, contact us at [email protected]

The original job offer can be found in Kit Job:
https://www.kitjob.ca/job/19517971/j270-manager-pharmacovigilance-medical-information-canada/?utm_source=html

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